Systems and methods for increased operating room efficiency

ABSTRACT

Systems, devices and methods to improve safety and efficiency in an operating room comprise providing a suture package that holds new suture needles and needle receptacles for storing used needles. The devices can be safely worn for the surgeon to self-dispense new suture needles in the near surgical field and to secure the used needles into a needle trap or a needle retainer located on his extremity, on his operative instruments or on the surgical drapes. The device may provide automated and/or simplified needle counting both during use and after removal from the surgical field. The device may be configured for ergonomic and efficient use so as to minimize the actions and motions of the surgeon to dispense and secure the needle.

RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.16/566,704, filed Sep. 10, 2019, which is a continuation of U.S. patentapplication Ser. No. 16/167,369, filed Oct. 22, 2018, now U.S. Pat. No.10,478,177, issued Nov. 19, 2019, which is a continuation of U.S. patentapplication Ser. No. 15/895,896, filed Feb. 13, 2018, now U.S. Pat. No.10,485,534, issued Nov. 26, 2019, which is a continuation ofInternational Patent Application No. PCT/US2016/059599, filed Oct. 28,2016, 2016, published as WIPO Publication No. WO 2017/075548 on May 4,2017, which claims the benefit under 35 U.S.C. § 119(e) of U.S.Provisional Application No. 62/248,029, filed Oct. 29, 2015, the entiredisclosures of which are incorporated herein by this reference.

The subject matter of the present application is related to U.S.application Ser. No. 14/697,050, filed on Apr. 27, 2015, now U.S. Pat.No. 9,451,949, issued Sep. 27, 2016, and International Application No.PCT/US2015/027659, filed Apr. 24, 2015, published as WIPO PublicationNo. WO 2015/164830 on Oct. 29, 2015, the entire contents of which areincorporated herein by this reference.

BACKGROUND

The use of an operating room can present expensive medical servicecosts. It is estimated that operating room time can cost between about$30 to $100 per minute. An operating room must be sterilized before eachoperation and the medical staff must also prepare for the operation.Because each employee is usually paid for their time in the operatingroom, the operating room use costs can be very high. By increasing theefficiency of the employees within the operating room, the time for eachprocedure can be reduced and the cost of the surgery can also bereduced. Further, it is important to account for surgical objects suchas needles and sponges during a surgical procedure. If a needle becomeslost during the surgery, steps need to be taken to ensure patient safetyand that the needle has not been accidently left in the patient.Accounting for needles during a surgical procedure in an accurate mannercan be time-consuming. Therefore, it would be desirable to provideimproved ways to keep track of used needles in an operating room. Also,needle puncture through a surgical glove can present risks to operatingroom personnel.

The process of loading a needle holder is often carried out by thosepersonnel assisting the surgeon in the process of surgery. A scrubtechnician or surgical assistant can pass the loaded needle holder tothe surgeon. Both unused needles not yet having been used and thosealready used needles can be maintained on an instrument tray such as aMayo stand, and an accounting of the needles is often made by thesurgical assistant and circulating nurse during the course of surgery.

At the time of surgical incision wound closure, or other tissue repair,during which multiple armed sutures are to be utilized, the surgicalassistant can be fully focused on the needs of the surgeon. Theassistant passes the loaded needle holder to the surgeon's hand for use.

Used needles may be dispensed and accounted for in a less than optimaland safe manner. As a substitute for having the loaded needle driverpassed to the surgeon, the surgeon may awkwardly load the armed suturehimself. This often requires the surgeon turning to the instrument tray(e.g., Mayo stand), locating the suture package, and grasping andorienting the package such that the needle can be effectively andproperly loaded onto the needle holder, which takes additional time andmovement than would be ideal and undesirably directs the surgeonsattention away from the patient.

In prior neutral zone approach, objects and instruments that are passedbetween a scrub tech and a surgeon must be placed in a neutral zonearea. The process may require a scrub tech to place the object into theneutral zone and the surgeon cannot pick up the object until the scrubtech's hands are removed from the neutral zone. Similarly when thesurgeon no longer needs a surgical object, it is placed in the neutralzone and the surgeon's hand removed. This system is less than idealbecause the surgeon and scrub tech must often be very careful andclearly communicate and look at the neutral zone, away from the site ofthe operation, when any objects are passed. This can be particularlydifficult when trying to perform actions quickly which can easily happenin an operating room procedure, for example when attempting to save apatient's life.

In many currently used suture handling methods and systems, the surgeoncan be handed a needle driver with an armed suture needle. The surgeonmay drive the needle through the flesh of the patient and then hands theneedle driver with used needle to the scrub tech. The scrub tech thenmoves the used needle away from the surgical field and removes the usedneedle. The scrub tech then places a new armed needle in the needledriver and then hands the surgeon the needle driver. The describedprocess is repeated, and results in more movement than would be ideal.

In addition to being highly inefficient, such systems can also have poormicro-ergonomics.

In light of the above, improved methods and apparatus are needed toimprove operating rooms. Ideally such methods and apparatus wouldprovide improved efficiency, outcomes, needle handling, counting, andsafety.

SUMMARY

The present invention relates to systems and methods for increasingoperating room efficiency. Although specific reference is made todispensing and securing needles, the embodiments described herein arewell suited for use with many types of objects used in an operatingroom, such as sharp objects.

Systems and methods for improving operating room efficiency as describedherein improve the manner in which surgeons' access and dispose ofobjects used in surgery such as sutures and needles. The methods andapparatus disclosed herein can improve safety by decreasing the numberof needle passes between the surgeon and assistant, and by placingneedles in a receptacle prior to being passed from the surgeon to theassistant.

Many embodiments relate to the dispensing and loading of surgicalneedles that can be facilitated and made more efficient and ergonomic byassociating the needles, sutures and the packaging onto the surgeon'sforearm, wrist, and/or hand. Furthermore and in many embodiments, theinvention relates to the association of used needle temporary storagedevice as associated with the surgeon's forearm, wrist, and/or hand. Theassociation of the surgeon's forearm wrist and/or hand can beaccomplished in many ways, such as with mounting onto the surgeon'sforearm wrist or hand, mounting to a surgical instrument such asforceps, or with a support extending into a near surgical field of thesurgeon, and combinations thereof. Packaging and devices as describedherein facilitate the safe and efficient dispensing of armed sutures inthe proper orientation from the surgeon's forearm, wrist, and/or handfor use by the surgeon. Alternatively or in combination, the sutures canbe dispensed from a support coupled to a surgical instrument such asforceps and the dispensed needles subsequently placed in the receptacle.The methods and apparatus disclosed herein allow the physician toself-load the needle into the needle driver, self-place the dispensedneedle into a used needle receptacle, and optionally install the suturein the patient, which have the benefits of decreasing reliance onassistants, improving operating room efficiency and the safety of needlehandling. In many embodiments, one or more needles can be secured in thereceptacle prior to passing the needle to an assistant, which increasessafety by placing the needle in the receptacle prior to passing to theassistant. A plurality of needles can be surgeon dispensed and surgeonplaced in the container, such that the safety and efficiency can beincreased by decreasing the number of passes between the surgeon andassistant.

In many embodiments, an “armed” suture comprises a suture that has asurgical needle attached. Furthermore, packages of armed sutures oftencontain more than one such suture and needle. The package may containnot only one, but also perhaps five and possibly more such as 8 or moresutures and needles. In the course of surgery, many such armed suturescan often be used, each needing to be “loaded” onto the needle holder or“needle driver”. The surgeon can hold the needle driver in his dominanthand and a tissue forceps in the non-dominant hand in order tomanipulate and hold tissues to be sutured. Thus the surgeon can use bothhands when suturing to self-dispense and self-secure the dispensedneedles.

By associating the suture packaging and the enclosed armed sutures ontothe surgeon's forearm, wrist or hand, the surgeon can more efficientlyaccess armed sutures for loading onto the needle driver. Furthermore,the surgeon's forearm, wrist or hand can also provide a location forattachment of a used needle temporary or permanent storage device. Inmany embodiments, by associating the suture package to the volar ordorsal-radial region of the surgeon's non-dominant forearm, wrist, orhand, the mechanics of grasping the needle with the needle holder can befacilitated. Such an approach allows the surgeon to instantly reorientthe suture pack and into a more appropriate position such that graspingthe needles with the needle holder is facilitated. Associating thepackage with the surgeon's non-dominant extremity can allow the surgeonto, without significant body motion or without needing to grasp thepackage with his non dominant hand, reposition the needle package andneedles in space such that they are readily accessible to be graspedwith the needle driver.

In many embodiments a forearm-mounted system comprises a needle trapthat can include an integrated suture pack mount that can be easilyattachable to and detachable from a needle puncture resistant barrierworn on a forearm. The puncture resistant barrier provides a stablesurface for dispensing of new sutures/needles from a standard suturepack and securement of contaminated needles after the stitch iscompleted. A benefit of the integration of the suture pack mount withthe needle trap is that this configuration can enable real timeproximity reconciliation within the near surgical field of used andunused needles. Integration of the suture pack mount with the needletrap within the near surgical field enables the surgeon to maintainfocus on the incision closure process without having to divert visualattention to locate the needle securement container and deposit the usedneedles.

In many embodiments, the puncture resistant barrier provides protectionto at least the volar surface of a forearm from inadvertent needlesticks and may also provide additional protection to the dorsal surfaceof a forearm. The puncture resistant barrier can also provide additionalmounting surfaces for tool holders, running-suture spools, or otherprocedure specific materials that are optimally located in the nearsurgical field. The puncture resistant barrier can provide protectionfrom sharps and can be comfortable, anatomically conformal, lightweight,unobtrusive, and quickly attachable to the surgeon's forearm with onehand.

The present disclosure provides multiple concepts, technologies anddevices by which currently available armed sutures and the packages fromwhich they are dispensed can be associated with the surgeon's forearm,wrist or hand for easier and more efficient loading by the surgeon,reducing the need for assistance from the scrub technician. Furthermore,disclosed herein are newly designed suture packages or modifications tocurrently available packages, which can incorporate concepts andtechnologies that allow for easy and efficient attachment of single ormultiple suture packages to the support platform on the surgeon'sforearm, wrist or hand or other support. The embodiments disclosedherein are well suited for use when the surgeon is gowned and gloved.The needle storage devices for dispensed used needles can also beassociated with the surgeon's forearm, wrist or hand, as well asprotective barriers and mechanisms that decrease the likelihood ofneedle stick to the surgeon.

The methods and apparatus disclosed herein allow a person who is closingan incision or wound with suture needles to reconcile needles dispensedfrom a suture pack with needles secured in a needle receptacle, in orderto ensure that all needles used in a surgical procedure are accountedfor. In many instances, the surgeon closing the incision can dispensesuture needles from a suture pack in the near surgical field and placeneedles removed from the suture pack into a secure container within thenear surgical field, and count the needles removed from the suture packand the needles placed in the needle receptacle while the suture packand needle receptacle remain in the near surgical field in order toreconcile the needles in the near surgical field. The reconciled needlessecured in the receptacle and any remaining needles in the suture packcan then be passed from the near surgical field to another personoutside the near surgical field or to a neutral zone. This needlereconciliation within the near surgical field allows the surgeon andothers to act quickly if a needle is not accounted for and to takecorrective action, for example by finding the missing needle. In manyinstances, needle reconciliation within the near surgical field alsoallows the surgeon to notice the missing needle sooner thanreconciliation outside the near surgical field, and can make it easierto find the missing needle because the needle is missing for a shortertime. Needle reconciliation within the near surgical field also allowsthe surgeon or other person closing an incision or wound to have greatercontrol over the surgical procedure, and also decreases the staffingrequirements for surgery and associated costs. Although reference ismade to needle reconciliation within the near surgical field outside ofthe patient, the methods and apparatus disclosed herein are well suitedfor needle reconciliation within the patient, for example within thepatient during laparoscopic and robotic surgery.

Aspects of the present disclosure may provide barriers for placement ona forearm of a user. An exemplary barrier may comprise a curved shelldefining a longitudinal axis extending between a proximal end and adistal end, with the curved shell extending with curvature about thelongitudinal axis.

In many embodiments, the proximal end of the shell defines across-section with a long axis and a short axis, the distal end of theshell defines a cross-section with a long axis and a short axis, and thelong axis of the proximal end is rotated about the longitudinal axisrelative to the long axis of the distal end.

In many embodiments, the barrier long axis of the distal end is rotatedrelative to the long axis of the proximal end when placed on a forearmof a user, the proximal end is located toward an elbow of the user, andthe distal end is located toward a wrist of the user when placed.

In many embodiments, the barrier comprises a pre-formed self-supportingbarrier shaped to define the long axis on the proximal end and the shortaxis on the distal end as opposing edges of the barrier are urged towardeach other.

In many embodiments, the long axis of the proximal end is longer thanthe long axis of the distal end.

In many embodiments, the proximal end comprises a short axis and thedistal end comprises a short axis, and the short axis of the proximalend is longer than the short axis of the distal end. The long axis ofthe distal end may be shorter than the short axis of the proximal end.

In many embodiments, the barrier may comprise a thermoformed sheet ofmaterial having substantially uniform thickness.

In many embodiments, the barrier comprises a preformed self-supportingstructure.

In many embodiments, the barrier comprises a dorsal aspect having adorsal length extending between the proximal end and the distal end, aradial aspect having a radial length extending between the proximal endand the distal end, and a volar aspect having a volar length extendingbetween the proximal end and the distal end. The radial aspect may bedisposed between the dorsal aspect and the volar aspect. The radiallength may be shorter than the dorsal length and the volar length. Thebarrier may comprise indicia on the radial aspect for a user to alignthe barrier with a radial ridge of the forearm of the user.

In many embodiments, the barrier may further comprise a proximal tabhaving a proximal tab length and a distal tab having a distal tablength, the proximal tab longer than the distal tab. The distal tablength may be within a range from about 25% to about 75% of the proximaltab length. The proximal tab and the distal tab may be preformed to havea curved shape extending around the longitudinal axis in a free standingconfiguration.

In many embodiments, the barrier is shaped to fit a left forearm of auser or a right forearm of a user.

In many embodiments, the barrier comprises a dorsal taper on a dorsalside between the proximal end and the distal end and a volar taper on avolar side between the proximal end and the distal end. The volar tapermay be greater than the dorsal taper.

In many embodiments, the barrier comprises a placed configuration whenopposite edges on opposite sides have been drawn toward each other.

In many embodiments, the barrier comprises a placed configuration whenopposite edges on opposite sides have been drawn toward each other andwherein dorsal, volar and radial aspects of the barrier define aproximal center at the proximal end and a distal center at a distal end,an intermediate portion of the barrier defines an intermediate centerwith intermediate dorsal volar and radial aspects, and the center of theintermediate portion is located away from a straight line extendingbetween the proximal center and the distal center. The plurality ofintermediate dorsal, radial, and volar portions may define a pluralityof intermediate centers. The proximal center, the intermediate center,and the plurality of intermediate centers may define a curved pathextending between the proximal center and the distal center. Aperpendicular cross-section of the proximal portion through the proximalpoint may define a plane and an orthogonal axis extending from theproximal center perpendicular to the plane. The distal center may beoffset from the orthogonal axis by an amount within a range from about 1cm to about 4 cm.

The barrier may be in a variety of dimensions. The barrier may comprisea thickness within a range from about 0.4 mm to about 5 mm. The maycomprise a longitudinal length within a range from about 6 inches toabout 11 inches. The barrier may comprise a ratio of the distance acrossthe proximal end to the distance across the distal end within a rangefrom about 1.1 to about 1.5.

In many embodiments, the barrier may comprises a pre-formed shapedbarrier. The barrier may comprise a volar edge on a volar side and adorsal edge on a dorsal side. The volar edge may separate from thedorsal edge when advanced over the forearm for placement. An amount offorce to separate the volar edge from the dorsal by about one inch froma free standing configuration may be within a range from about 25 gramsto about 400 grams, or from about 50 grams to about 150 grams.

In many embodiments, the barrier comprises a shell and an underlyingfoam which extends distally beyond the distal border of the shell of thebarrier. The foam may curve over a leading distal edge of the shell topad the interface of the shell when the barrier impinges on the wrist toprovide comfort.

In many embodiments, the barrier comprises a shell and an underlyingfoam which extends distally beyond the distal border of the shell of thebarrier to pad the interface of the shell when the barrier impinges onthe wrist to provide comfort.

In many embodiments, the barrier may comprise a shell and an underlyingfoam which curves over a leading distal edge of the shell to pad theinterface of the shell when the barrier impinges on the wrist to providecomfort.

In many embodiments, the barrier may comprise a shell and a distal edgeof the shell has a curvature with a diameter equal to the thickness ofthe shell.

In many embodiments, the barrier may comprise a shell and a distal endof the shell curves away from the forearm of a user, such as with aradius of curvature of between 2 mm and 5 mm.

In many embodiments, the barrier comprises a shell having a radialcurvature at a distal edge of shell with displacement within a rangefrom about 3 mm to 1.5 cm to distribute a load of the barrier on a wristof a user.

In many embodiments, the barrier comprises a shell and a foam paddingthe distal edge of the shell.

In many embodiments, the barrier may comprise a thickened distal edge.

In many embodiments, the barrier may be configured to distribute a loadwhen device abuts the dorsal or radial or volar aspect of the wrist withmotion of the wrist.

Aspects of the present invention include barriers for placement on aforearm of a user. An exemplary barrier may comprise a curved shelldefining a longitudinal axis extending between a proximal end and adistal end. The curved shell may extend with a curvature about thelongitudinal axis. The proximal end of the shell may define across-section. The distal end of the shell may define a cross-section.The barrier may comprise a pre-formed shaped barrier. The barrier maycomprise a volar edge on a volar side and a dorsal edge on a dorsalside. The volar edge may separate from the dorsal edge when advancedover the forearm for placement. An amount of force to separate the volaredge from the dorsal by about one inch from a free standingconfiguration may be within a range from about 25 grams to about 400grams, or from about 50 grams to about 150 grams.

Aspects of the present invention may provide a method comprisingproviding a barrier as disclosed herein.

Aspects of the present invention may provide needle receptacles. Anexemplary needle receptacle may comprise a lower structure that has anentry zone and a secure zone, an upper structure that has a secure zone,a needle slot for receiving one or more suture needles between the lowerstructure and the upper structure, and an upper needle driver slot thatextends through a portion of the upper structure and a lower needledriver slot that extends through portion of the lower structure. A lowerprotrusion on a bottom side of the lower structure may comprise a heightsufficient to provide clearance for the needle driver when a needlegrasped away from a tip of the needle driver advances along the needleslot. The lower protrusion may comprise a standout extending along thelower needle driver slot.

Another exemplary needle receptacle may comprise a housing comprising alower structure and an upper structure. The upper structure may comprisean optically transmissive material and the lower structure may comprisean optically transmissive material in order to view needles within asecure zone of the receptacle with backlight illumination. The upperportion may comprise a transparent material to view the needles, and thelower portion may comprise a translucent material to pass backlightillumination light to the needles. The needle receptacle may furthercomprise a slot through the upper structure in order to view needleswithin a secure zone of the receptacle. The upper structure may have alongitudinal slot to receive a needle driver. The secure zone maycomprise an elongate needle slot to receive a plurality of needles. Theelongate needle slot may extend between the upper structure and thelower structure. The needles in the needle slot can be viewed throughthe top structure with backlight illumination through the lowerstructure.

Another exemplary needle receptacle may comprise a lower structure thathas an entry zone and a secure zone, an upper structure that has asecure zone, and a needle slot for receiving one or more suture needlesbetween the lower structure and the upper structure. A plurality ofprotrusions may extend along the needle slot with a periodicity in orderto provide tactile feedback to a user to indicate a position of theneedle along the needle slot.

Another exemplary needle receptacle may comprise a lower structure thathas an entry zone and a secure zone, an upper structure that has asecure zone and a needle driver slot extending along the secure zone,and a needle slot for receiving one or more suture needles between thelower structure and the upper structure. A plurality of protrusions mayextend along the needle driver slot to provide tactile feedback to auser as to the depth of the needle driver along the needle driver slot.The plurality of protrusions may comprise one or more of teeth, inclinedteeth, ratchet teeth or circular cutouts. The plurality of protrusionsmay comprise one or more of teeth, inclined teeth, ratchet teeth orcircular cutouts, flaps, bristles, or filaments. The plurality ofprotrusions may be arranged with periodicity to provide an indication ofdepth of the needle driver along the needle driver slot.

Another exemplary needle receptacle may comprise a lower structure thathas an entry zone and a secure zone, an upper structure that has asecure zone, and a needle slot for receiving one or more suture needlesbetween the lower structure and the upper structure. A plurality ofasymmetric protrusions may extend along the needle slot in order toinhibit removal of the needle along the needle slot. Each of theplurality of asymmetric protrusions may comprise a base extending to apeak. The base may comprise a distal edge toward an entrance of the slotand a proximal edge toward a stop on a proximal end of the slot. Thepeak may be located closer to the proximal edge than the distal edge.The plurality of asymmetric protrusions may comprise one or more ofbristles or fibers inclined proximally toward a stop in order tofacilitate movement toward the stop and inhibit movement toward anopening of the slot through which the needle is passed for placement inthe secure zone. The entry zone may be at a distal end of the needlereceptacle and the secure zone may be at a proximal end of the needlereceptacle. The plurality of asymmetric protrusions may comprise one ormore of bristles or fibers inclined towards a stop in order tofacilitate movement toward the stop and inhibit movement toward anopening of the slot through which the needle is passed for placement inthe secure zone.

Another needle receptacle may comprise a structure to receive a needlewith resistance or force to remove the needle, wherein an amount ofresistance or force to remove the needle is within a range from about 5grams to 250 grams, within a range from about 15 grams to about 150grams, within a range from about 25 grams to about 100 grams, or withina range from about 30 grams to about 90 grams. The amount of force toremove the needle may be greater than the amount of force to insert theneedle. The needle receptacle may comprise a needle slot, and the amountof force may comprise an amount of force to advance the needle along theneedle slot. The needle receptacle may comprise a needle driver slot,and the amount of force may comprise an amount of force to advance theneedle driver along the needle driver slot to secure the needle in theneedle slot.

Aspects of the present invention may provide a method comprising a stepof inserting a needle into a needle receptacle. The needle receptaclemay resist insertion of the needle with an amount of force within arange from about 5 grams to 250 grams, within a range from about 15grams to about 150 grams, within a range from about 25 grams to about100 grams, or within a range from about 30 grams to about 90 grams. Theamount of force to remove the needle may be greater than the amount offorce to insert the needle.

Aspects of the present invention may provide needle traps. An exemplaryneedle trap may comprise a landing zone and a secure zone. The landingzone may be substantially coplanar with the secure zone.

Aspects of the present invention may provide a method comprising stepsof moving a needle to a landing zone of a needle receptacle and slidingthe needle from the landing zone into a secure zone of the needlereceptacle.

Aspects of the present invention may provide a receptacle comprising aslotted structure that allows a tip and a tail of the needle to besubstantially enclosed while suspending a mid-portion of the needle inthe slot.

Aspects of the present invention may provide a needle receptaclecomprising a slot along a secure zone. The slot may be sized smallerthan a finger tip having a size of about 10 mm.

Aspects of the present invention may provide a needle receptaclecomprising a needle groove having a thickness small enough to inhibitrotational movement of the needle out of the needle groove.

Aspects of the present invention may provide sterile barrier kits. Anexemplary sterile barrier kit may comprise a sterile package and asterile barrier contained within the package. The kit may be configuredfor one or more of regional anesthesia, spinal anesthesia, emergencyroom suturing, or intravenous (IV) line placement. The kit may beconfigured to one or more of regional anesthesia, spinal anesthesia,emergency room suturing, intravenous (IV) line, arterial line, orcentral line placement.

In the needle receptacles disclosed herein, the receptacle may be sizedto a range of needles, and may optionally comprise a smaller slot forsmaller needle drivers, in which the slot comprises a width of no morethan a diameter of a largest needle for which the trap is designed tostore.

A longitudinal slot for the needle driver may comprise a through andthrough slot, in which the slot extends though both sides of thereceptacle.

A longitudinal slot or groove for the needle driver may comprise a lowersolid wall, in which the wall is located at a sufficient depth to allowthe tip of the needle driver to protrude beyond the needle securementslot plane. The needle driver groove or slot may extend beneath theneedle slot by a distance within a range from about 0.1 mm to about 10mm.

In the needle receptacles disclosed herein, the receptacle may comprisea longitudinal slot bounded by a structure to one or more sides of theslot that creates a varying resistance to translation as the needle isdrawn along the slot. Optionally, the varying resistance may be providedwith one or more of discrete or asymmetric features that protrude intothe needle slot, in order to increase compression of the needle andprovide tactile feedback as the needle is drawn along the slot.

The needle receptacle may comprise a secure zone, can be applied to theforearm, and may comprise a width of less than 12 cm and a length ofless than 26 cm.

A compressive member may be configured to secure a needle and provideresistance to movement of the needle against an apposed surface. Thefoam structure may comprise a gap of less than 2 mm between the foam andthe apposed surface.

Aspects of the present disclosure may provide a method of inserting aneedle into a needle receptacle. The method may comprise steps ofplacing the needle at an entry zone of the needle receptacle coupled toa forearm and moving the needle along a plane of the forearm to securethe needle within a housing of the needle receptacle.

The barrier may comprise a recess in an outer surface of the barrier.The recess may be configured to receive at least a portion of a needlereceptacle therein to couple the needle receptacle to the barrier in alow profile.

The barrier may comprise an integrated needle receptacle such that theneedle receptacle is provided on the barrier in a low profile.

The needle receptacle may comprise a needle driver slot cover configuredto at least partially cover a longitudinal needle driver slot of theneedle receptacle to reduce risk of exposure of needle tips through theneedle driver slot. The needle driver slot cover may comprise one ormore flexible strips configured to elastically deform when a needledriver tip is translated along the needle driver slot. The needle driverslot cover may comprise a flexible strip disposed over the needle driverslot. The flexible strip may comprise a longitudinal slit positionedover the needle driver slot and extending longitudinally along theneedle driver slot. The flexible strip may further comprise a pluralityof vertical slits disposed over a length of the needle driver slot andextending orthogonally with respect to the longitudinal slit. The needledriver slot cover may comprise a transparent material. The needle driverslot cover may be slidably coupled to the needle receptacle andconfigured to slide to expose or cover the needle driver slot when theneedle driver tip is translated along the needle driver slot. The needledriver slot cover may be configured to slide along a longitudinal axisof the needle driver slot. The needle driver slot cover may beconfigured to slide along an axis orthogonal to the longitudinal axis ofthe needle driver slot.

The needle receptacle may comprise a compressive member mountedlaterally along a first longitudinal edge of a needle driver slot. Thecompressive member may be configured to be displaced by translation of aneedle driver tip along the needle driver slot. Upon removal of theneedle driver tip from the needle driver slot, exposed ends of a needlemay be compressively pushed toward a second longitudinal edge of theneedle driver slot opposite the first edge. The compressive member maybe configured to provide a compressive force in a direction orthogonalto a longitudinal axis of the needle driver slot.

A housing of the needle receptacle may comprises a light guide. Theneedle receptacle may be coupled to a light source configured totransmit light to the light guide to provide backlighting.

A housing of the needle receptacle may comprise a light scatteringmaterial or surface to provide for non-uniform light transmissiontherethrough. The light scattering surface may comprise a surface of thelower or upper structure. The light scattering surface may comprise aroughened surface. The light scattering surface may comprise asandblasted surface.

Aspects of the present disclosure may provide apparatuses for dispensingand securing a swaged needle. An exemplary apparatus may comprise ahousing and a swaged needle. The housing may comprise a top portion, abottom portion, and a side wall. The swaged needle may be coupled to thetop portion of the housing. The swaged needle may comprise an attachedsuture. The attached suture may be wrapped around the side wall. Aleading end of the swaged needle may be covered. The housing maycomprise a spindle configured to allow rotation of the housing about acentral axis of the housing. The apparatus may further comprise amounting mechanism to mount the apparatus to a barrier. A height of thehousing may be in a range from about 0.3 mm to about 15 mm, such as arange from about 1.5 cm to about 8 cm. The apparatus may be configuredto couple to another identical apparatus in a stacked configuration. Thehousing may comprise a lid coupled to the top portion. The swaged needlemay be covered by the lid. The top portion of the housing may comprise aslot to receive the leading end of the swaged needle and secure theswaged needle thereto.

Aspects of the present disclosure may provide apparatuses for dispensingand securing a swaged needle. An exemplary apparatus may comprise ahousing, a plurality of spindles, and a swaged needle. The housing maycomprise a bottom portion and a side wall extending from the bottomportion. The plurality of spindles may extend from a surface of thebottom portion. The swaged needle may be coupled to the housing. Theswaged needle may comprise an attached suture. The attached suture maybe wrapped around at least two of the plurality of spindles. Theplurality of spindles may be arranged on the bottom portion in pairs andthe suture may be wrapped around a first pair of spindles. The apparatusmay further comprise a second swaged needle coupled to the housing. Thesecond swaged needle may comprise an attached second suture. The secondsuture may be wrapped around a second pair of spindles.

Aspects of the present disclosure may provide needle receptacles formounting to a surgical tool. An exemplary needle receptacle may comprisea housing, a tool-mounting interface, and a coupling mechanism. Thehousing may comprise a planar needle slot to receive a needle and securethe needle therein. The tool-mounting interface may be configured tocouple to a distal end of the surgical tool. The coupling mechanism maybe configured to couple the housing to the tool-mounting interface. Thehousing may be configured to receive at least 5 needles therein. Thetool-mounting interface may comprise an elastomeric cap configured tofit over the distal end of the surgical tool. The housing may comprise arigid enclosure configured to receive a plurality of needles in a planararray aligned along a length of the rigid enclosure. The housing maycomprise a circular array of compartments. Each compartment may beconfigured to receive a single needle therein. The circular array ofcompartments may be configured to rotate about a central axis of thehousing to allow access to each compartment.

A needle driver slot may comprise an upper groove and a lower groove.The upper groove and the lower groove may comprise rounded edges.

A needle driver slot may comprise an upper groove and a lower groove. Awidth of the upper groove may be greater than a width of the lowergroove.

A needle driver slot may comprise an upper groove and a lower groove.The upper groove and the lower groove may comprise beveled edges.

A needle driver slot may comprise an upper groove and a lower groove.The edges of the upper groove and lower groove may be angled andcollinear.

In the needle receptacles disclosed herein, the needle driver slot maycomprise an upper groove and a lower groove. The edges of the uppergroove and lower groove may correspond to a subsection of a prolongedcurving plane.

Aspects of the present disclosure may provide needle handling systems.An exemplary needle handling system may comprise a needle dispensingunit, a needle receptacle, and a barrier mounting base. The needledispensing unit may comprise a plurality of sterile needles securedtherein. The needle receptacle may comprise a planar needle slotconfigured to receive a plurality of used needles in a planar array. Thebarrier mounting base may comprise a top side and a bottom side. The topside may be configured to couple to the needle dispensing unit and theneedle receptacle. The bottom side may be configured to couple to abarrier. The barrier mounting base may comprise a first portionconfigured to couple to the needle dispensing unit and a second portionconfigured to couple to the needle receptacle. The barrier mounting basemay further comprise a hinge disposed between the first portion and thesecond portion to allow the first portion to bend with respect to thesecond portion.

The needle receptacle may comprise a first compressive member and asecond compressive member. The first compressive member may beconfigured to engage a leading end of a needle. The second compressivemember may be configured to engage a trailing end of the needle so as toentrap the needle between the compressive members.

A needle receptacle as in any one of the preceding claims, the needlereceptacle comprising one or more clips configured to receive andenclose one or more ends of a needle and apply compressive force to theone or more ends to secure the one or more ends therein.

Aspects of the present disclosure may provide a needle receptaclecomprising a housing and a rotatable cover coupled to the housing. Thehousing may comprise a plurality of compartments. Each compartment maybe configured to contain a single needle therein. The rotatable covermay be coupled to the housing. The rotatable cover may comprise awindow. The rotatable cover may be configured to rotate about a centralaxis of the housing to align the window with a single compartment toallow access to the single compartment through the window.

The methods, apparatuses, receptacles, kits, and barriers disclosedherein may further comprise associating a combination of both dispensingunit and used needle repository on the forceps.

In the methods, apparatuses, receptacles, kits, and barriers disclosedherein more than one setup of a suture package and needle receptacle maybe ready for use.

The methods, apparatuses, receptacles, kits, and barriers disclosedherein may further comprise a sterile disposable forceps, a needle andsuture package in combination with a used needle receptacle.

In the methods, apparatuses, receptacles, kits, and barriers disclosedherein, a sterile disposable forceps, a needle, and suture package incombination with a used needle receptacle may be co-manufactured into acommon package.

In the methods, apparatuses, receptacles, kits, and barriers disclosedherein, a balanced surgical forceps may have an attached needleretention device onto the forceps.

In the methods, apparatuses, receptacles, kits, and barriers disclosedherein, a configuration may comprise a back to back relationship of thesuture package and needle receptacle on opposing sides.

In the methods, apparatuses, receptacles, kits, and barriers disclosedherein, the suture package and needle receptacle may be attached to theforceps to allow for containment, coverage, securement, of both tip andend (tail) of one or more needles.

In the methods, apparatuses, receptacles, kits, and barriers disclosedherein, a forceps mounted needle receptacle may promote an organizeddeposition or array of used needles to facilitate counting andreconciliation of needle count.

In the methods, apparatuses, receptacles, kits, and barriers disclosedherein, the needle receptacle may be configured with a size and shapefor five needles and may comprise five zones, one for each needle.

The methods, apparatuses, receptacles, kits, and barriers disclosedherein may further comprise five tactile bumps to facilitatelocalization into individual zones.

The methods, apparatuses, receptacles, kits, and barriers disclosedherein may further comprise 2-20 tactile bumps to facilitatelocalization into individual zones.

The methods, apparatuses, receptacles, kits, and barriers disclosedherein may further comprise 5-8 tactile bumps to facilitate localizationinto individual zones.

The methods, apparatuses, receptacles, kits, and barriers disclosedherein may further comprise 3-10 tactile bumps to facilitatelocalization into individual zones.

The methods, apparatuses, receptacles, kits, and barriers disclosedherein may be further configured for back lighting to enhance needleprofile contrast.

The methods, apparatuses, receptacles, kits, and barriers disclosedherein may further comprise five zone specific light sources and may beconfigured to provide one light source on per needle into thereceptacle. Light sources may be located on the needle receptacle.

The methods, apparatuses, receptacles, kits, and barriers disclosedherein may further comprise five light sources or sensors on a trap in areceptacle. The light sources may be coupled with the barrier. Thebarrier may be configured with five lights sources that light upaccording to a number of needles in the trap in the receptacle.

The methods, apparatuses, receptacles, kits, and barriers disclosedherein may further comprise a translational slot cover with ratchetedcounting mechanism.

Aspects of the present disclosure may provide a needle apparatus whichmay comprise a pair of opposing needle receptacles. Each needlereceptacle may have a front side and a back side and an opening toreceive needles on the front side. The back sides may be oriented towardeach other and the front sides may be oriented away from each other.

Aspects of the present disclosure may provide a needle apparatus whichmay comprise a pair of opposing suture packages. Each suture package mayhave a front side and a back side. The front side may be open to accessa plurality of needles therefrom. The back sides may be oriented towardeach other and the front sides may be oriented away from each other.

Aspects of the present disclosure may provide a needle apparatus whichmay comprise a needle receptacle and a suture package. The needlereceptacle may have a front side and a back side and having an openingto receive needles on the front side. The suture package may have afront side and a back side. The front side may be open to access aplurality of needles therefrom. The back sides may be oriented towardeach other and the front sides may be oriented away from each other.

A needle apparatus as disclosed herein may further comprise an interfaceto mount the needle apparatus on a surgical instrument. The interfacemay optionally comprise a slot to receive a proximal end of theinstrument.

A needle apparatus as disclosed herein may further comprise an interfaceto mount the needle apparatus on forceps and the interface mayoptionally comprise a slot to receive a proximal end of the forceps.

A needle apparatus as disclosed herein may further comprise an interfaceto mount the needle apparatus on tweezers. The interface may optionallycomprise a slot to receive a proximal end of the tweezers. The interfacemay comprise an adhesive.

A needle apparatus as disclosed herein may have opposing back sideswhich are rotatable about a common axis.

A needle apparatus as disclosed herein may have opposing back sideswhich are independently rotatable about a common axis.

A needle apparatus as disclosed herein may further comprise a pair ofdisposable forceps.

A needle apparatus as disclosed herein may be sterile and containedwithin a sterile package.

A barrier as disclosed herein may comprise a padding layer and amechanical barrier layer. One or more magnets may be coupled to asurface of the mechanical barrier layer facing the padding layer suchthat the one or more magnets are disposed between the padding layer andthe mechanical barrier layer.

A barrier as disclosed herein may comprise a mechanical barrier layercomprising a polymer material.

A barrier as disclosed herein may barrier comprise a polymer materialwith a thickness in range from about 0.5 mm to about 5 mm.

Aspects of the present disclosure may provide methods for handlingsuture needles. In an exemplary method, a suture needle may be graspedwith a needle driver to dispense the suture needle from a suture packagemounted on a support. The dispensed suture needle may be placed into aneedle receptacle mounted on the support. A tip of the dispensed sutureneedle may be oriented away from a surgeon during the grasping step andthe placing step.

The dispensed suture needle may travel a variety of distances. Thedispensed suture needle may travel less than two feet from the graspingstep to the placing step. The suture needle may travel a round tripdistance of less than four feet from the grasping step to the placingstep. The suture needle may travel no more than two feet from the suturepack to a wound and no more than two feet from the wound to the needlereceptacle.

In many embodiments, the dispensed suture needle remains within a nearsurgical field during the steps of grasping and placing. The nearsurgical field may be bounded by a length extending from a front side ofa torso of a surgeon to an incision, a width extending between forearmsof the surgeon in a neutral rotation position, and a height extendingvertically from a height of the incision to shoulders of the surgeon.

In many embodiments, the suture package and the needle receptacle arearranged for the surgeon to dispense a plurality of needles from thesuture package and place the plurality of needles in the needlereceptacle without an external rotation of an arm of a surgeon withrespect to an anatomical neutral plane of the arm.

In many embodiments, the suture package and the needle receptacle arearranged for the surgeon to dispense a plurality of needles from thesuture package and place the plurality of needles in the needlereceptacle without an external rotation of an arm of a surgeon beyond acoronal plane of the surgeon.

In many embodiments, the suture package and the needle receptacle arearranged for the surgeon to dispense a plurality of needles from thesuture package and place the plurality of needles in the needlereceptacle without an external rotation of an arm of a surgeon beyond aplane perpendicular to the coronal plane of the surgeon at the surgeon'sshoulder.

In many embodiments, the suture package and the needle receptacle arearranged for the surgeon to dispense a plurality of needles from thesuture package and place the plurality of needles in the needlereceptacle without an external rotation of an arm of a surgeon beyond asagittal plane that bisects the coronal plane at the surgeon's shoulder.

In many embodiments, the suture package and the needle receptacle arearranged for the surgeon to dispense a plurality of needles from thesuture package and place the plurality of needles in the needlereceptacle without an external rotation of an arm of a surgeon beyond amid-sagittal plane of the surgeon.

In many embodiments, the near surgical field comprises a space disposedwithin one or more of about 2 feet of the incision, 1.5 feet of theincision or about 1 foot of the incision.

In many embodiments, the suture package and the needle receptacle areattached to the support.

In many embodiments, the method further comprises repeating the steps ofgrasping and placing until a plurality of suture needles has beendispensed from the suture package and placed into the needle receptacle.

In many embodiments, the dispensed suture needle is attached to asuture, and the method further comprises installing the suture into apatient with the dispensed suture needle and the needle driver. Thesteps of grasping, installing, and placing may be repeated until aplurality of sutures have been installed in the patient.

In many embodiments, the suture pack and the needle receptacle arearranged for a surgeon to perform the steps of grasping and placing withone hand.

In many embodiments, the support comprises a movable support controlledby a surgeon.

In many embodiments, the needle receptacle comprises a structure locatedto place into a stable configuration one or more reels of suture coupledto a swaged on needle in order to dispense suture of the swaged needlefrom the one or more reels stably supported on the needle receptacle.

In many embodiments, the suture pack comprises a structure located toplace into a stable configuration one or more reels of suture eachcoupled to a swaged on needle in order to dispense the one or more reelsof suture and needle from the structure stably supported on the suturepack.

In many embodiments, the suture pack comprises a structure located toplace into a stable configuration one or more reels of suture coupled toa swaged on needle in order to dispense suture of the swaged needle fromthe one or more reels stably supported on the suture pack.

In many embodiments, a suture attached to the dispensed suture needle iscut with one hand.

In many embodiments, the support comprises a barrier supported by asurgeon. The barrier may be coupled to a limb of the surgeon. Thebarrier may be releasably coupled to a limb of the surgeon. The suturepackage may be selected among a plurality of suture packages supportedon a tray, and the suture package may be placed on the barrier. Theneedle receptacle may be selected among a plurality of needlereceptacles supported on a tray, and the needle receptacle may be placedon the barrier.

In many embodiments, the suture package, the needle receptacle, and thesupport are sterile. One or more of the support or the barrier isconfigured for placement on a back portion of a hand of a surgeon withone or more structures extending from the barrier.

In many embodiments, the suture package and the needle receptaclecomprise a self-contained package capable of being passed together froma surgeon to an assistant and vice versa with a plurality of innocuousneedles supported with the suture package and the needle receptacle. Thesuture package may be attached to the needle receptacle. The suturepackage may be flexibly attached to the needle receptacle with a hingedsupport member. A combination of the suture package and needlereceptacle may be attached to a support on an extremity of the surgeon.A combination of the suture package and needle receptacle may attachconformably to the support on an extremity of the surgeon.

The suture pack may comprise a planar suture package, and the needlereceptacle may lie at an oblique angle of less than 45 degrees relativeto the planar suture package. The suture package and the needlereceptacle may each in contact with the support so as to decrease aprofile of the needle receptacle. The suture package may be assembledtogether on the support.

The suture package and the trap may at least partially overlap in orderto decrease size on barrier. The suture package and the trap may atleast partially overlap in order to decrease a footprint of the suturepackage and the trap on barrier. The package and the needle receptacletrap may overlap in a proximal to distal direction. The suture packageand the needle receptacle may overlap in a medial to lateral direction.The suture package and the needle receptacle may comprise an attachmentmechanism. The suture package may comprise a standard commerciallyavailable needle package.

A needle receptacle attachment mechanism may allow attachment of thesuture package to one or more of a lateral border or a distal border ofthe needle receptacle.

The step of coupling the barrier to a limb of the surgeon may compriseplacing the barrier over a volar portion of a forearm of the surgeon.

The needle receptacle may be placed over a volar forearm of the surgeon.The needle receptacle may comprise a planar structure placed over thevolar forearm. The needle receptacle may comprise a planar structureplaced over the volar forearm and optionally the planar structure may beplaced over a medial portion of the volar forearm. The needle receptaclemay be arranged over the volar forearm to allow easy insertion of a usedneedle when a hand holding needle holder is slightly supinated. Theneedle may be placed in the receptacle with rotation of an arm holding aneedle driver with shoulder joint rotation in order to align and placethe used needle into an opening of the needle receptacle.

The needle receptacle may be arranged over the volar forearm to alloweasy insertion of a used needle when a hand holding needle holder isslightly pronated. The needle may be placed in the receptacle withrotation of an arm holding a needle driver with shoulder joint rotationin order to align and place the used needle into an opening of theneedle receptacle.

The needle receptacle may comprise a longitudinal length, a transversewidth, and a height. The length may be greater than the width and theheight. The width may be greater than the height. The length may bewithin a range from about 4 cm to about 15 cm, the width may be within arange from about 3 cm to about 6 cm, and the height may be within arange from about 0.5 cm to about 2 cm.

The step of coupling the barrier to the limb of the surgeon may comprisesteps of providing legs that extend from sides of the barrier andengaging the legs on the limb of the surgeon to stabilize the barrier onthe forearm of the surgeon. The step of engaging the legs on the limb ofthe surgeon may comprise a step of engaging one or more of a distalportion or a proximal portion of a forearm of the surgeon. The legs maycomprise at least a plurality of legs for stable placement on one ormore the first portion or the second portion. The legs may comprise slapbracelets. The legs may comprise a first leg and a second leg. Themethod may further comprise a step of securing a first couplingmechanism on the first leg to a second coupling mechanism on the secondleg to secure the barrier to the limb of the surgeon.

The method may further comprise a step of coupling the suture package tothe barrier. The method may further comprise a step of coupling theneedle receptacle to the barrier. One or more of the support or thebarrier may comprise a barrier layer configured to protect the limb ofthe surgeon from contact with the suture needles.

The support may comprise a surgical tool held by a surgeon. The surgeonmay perform the steps of grasping and placing with one hand, whileholding the surgical tool with the other hand.

A plurality of suture packages may be mounted on the support.

The step of placing the dispensed suture needle into the needlereceptacle may comprise a step of rendering innocuous both ends of thedispensed suture needle within the needle receptacle.

The step of placing the dispensed suture needle into the needlereceptacle may comprise a step of compressing a component of the needlereceptacle against a tip of the dispensed suture needle.

The step of placing the dispensed suture needle into the needlereceptacle may comprise a step of placing the dispensed suture needle incontact with a foam material in the needle receptacle.

The step of placing the dispensed suture needle into the needlereceptacle may comprise placing a tip of the dispensed suture needleinto a tapered structure that guides the dispensed suture needle intothe needle receptacle.

The method may further comprise a step of actuating a lever coupled to adoor of the needle receptacle to open the door. The method may furthercomprise a step of inserting the dispensed suture needle through thedoor in the needle receptacle. The method may further comprise a step ofactuating the lever to close the door.

The method may further comprise a step of rotating the support so thatthe suture package faces the needle drive before grasping the sutureneedle with the needle driver.

The method may further comprise a step of rotating the support so thatthe needle receptacle faces the needle driver before placing thedispensed suture needle into the needle receptacle with the needledriver.

The needle receptacle may comprise a plurality of channels separated bydividers. The step of placing the dispensed suture needle into theneedle receptacle may comprise a step of placing the dispensed sutureneedle into one of the plurality of channels. A plurality of sutureneedles may be dispensed from the suture package. The step of placingthe suture needle into the needle receptacle may comprise placing eachof the plurality of dispensed suture needles into a different one of theplurality of channels. The dividers may surround one or more of aproximal end or a distal end of the dispensed suture needle.

The needle receptacle may comprise a transparent structure.

The support may be coupled to a proximal portion of surgical forceps.

One or more of the suture package or the needle receptacle may becoupled to a proximal portion of surgical forceps.

The suture package and the needle receptacle may be arranged for asurgeon to count a plurality of undispensed needles and a plurality ofdispensed needles within a near surgical field.

The suture package and the needle receptacle may be arranged for asurgeon to maintain a needle inventory within a near surgical field.

The suture package and the needle receptacle may be arranged for asurgeon to reconcile a needle inventory within a near surgical field.

The step of placing the dispensed suture needle into a needle receptaclemounted on the support may further comprise a step of securing theneedle to the needle receptacle.

Aspects of the present disclosure provide apparatuses for handlingsuture needles. The apparatus may comprise a suture package, a needlereceptacle, and a support. The suture package may be configured todispense a plurality of suture needles. The needle receptacle may beconfigured to store a plurality of dispensed suture needles. The supportmay be configured to support one or more of the suture package or theneedle receptacle.

In many embodiments, the needle receptacle is arranged to place thesuture needle in the receptacle with a tip of the suture needle orientedaway from the surgeon.

In many embodiments, the needle receptacle is arranged to place thesuture needle in the receptacle with a tip of the suture needle orientedaway from a direction of translation of the suture needle into theneedle receptacle.

In many embodiments, the suture needle comprises a curved suture needleand the needle receptacle is arranged to place the suture needle in thereceptacle with each end of the suture needle oriented away from thesurgeon.

In many embodiments, the needle receptacle comprises a structure toreceive the suture package and stably support the suture package.

In many embodiments, the suture package and the needle receptacle arearranged for the surgeon to dispense a plurality of needles from thesuture package and place the plurality of needles in the needlereceptacle without an external rotation of an arm of a surgeon withrespect to an anatomical neutral plane of the arm.

In many embodiments, the suture package and the needle receptacle arearranged for the surgeon to dispense a plurality of needles from thesuture package and place the plurality of needles in the needlereceptacle without an external rotation of an arm of a surgeon outside anear surgical field of the surgeon.

In many embodiments, the needle receptacle comprises a structure locatedto place into a stable configuration one or more reels of suture coupledto a swaged on needle in order to dispense suture of the swaged needlefrom the one or more reels stably supported on the needle receptacle.

In many embodiments, the needle receptacle comprises a structure locatedto place into a stable configuration one or more reels of suture eachcoupled to a swaged on needle in order to dispense suture of the swagedneedle from the one or more reels stably supported by a common basemounted to one of the group selected from: the a barrier on an arm of asurgeon, a drape over the patient, and a support.

In many embodiments, the apparatus further comprises a cutter arrangedwith the support in order to cut a suture of the suture needle with onehand.

In many embodiments, the apparatus further comprises a sterile trayhaving a plurality of suture packages supported thereon.

In many embodiments, the suture package, the needle receptacle and thesupport are sterile.

In many embodiments, one or more of the support or the platform isconfigured for placement on a back portion of a hand of a surgeon withone or more structures extending from the platform.

In many embodiments, the support is configured to attach to the suturepackage and to the needle receptacle in order to stably support thesuture package and the needle receptacle on the support and in order toinhibit sliding or falling of the suture package and the needlereceptacle from the support when the support is inverted or inclined andwherein the support is configured to release the suture package and theneedle receptacle.

In many embodiments, the suture pack and the needle receptacle arearranged for a surgeon to perform the steps of grasping and placing withone hand.

In many embodiments, the support comprises a movable support configuredto be controlled by a surgeon.

In many embodiments, the support comprises a platform configured to besupported by a surgeon.

In many embodiments, the support comprises a platform configured to besupported by one of the group selected from: a surgeon, a drape, and, amount coupled to the surgical table, and a stable mount. The platformmay comprise a coupling configured to couple the platform to a limb ofthe surgeon. The coupling may comprise one or more legs that extend fromsides of the platform. The legs may be configured to engage the limb ofthe surgeon. The coupling may comprise slap bracelets. One or more ofthe support or the platform may comprise a barrier configured to protectthe surgeon from contact with one or more ends of a dispensed sutureneedle.

In many embodiments, the support comprises a platform coupled to anadjustable support structure to place the platform within a nearsurgical field.

In many embodiments, the support comprises a platform is within a nearsurgical field and coupled to one of the group consisting of: anadjustable support structure, a stable mount, and a drape.

In many embodiments, the support is configured to couple to surgicalforceps configured to engage tissue with pinching motion. The supportmay be configured to couple to a proximal end of the surgical forceps.The surgical forceps may comprise one or more of Adson forceps or Bonneyforceps. The apparatus may weigh less than 45 grams. The apparatus mayfurther comprise a coupling to couple the suture package and the needlereceptacle to a proximal portion of the surgical tool. The apparatus mayfurther comprise a suture package holder configured to support one ormore suture packages. The suture package holder may be coupled to aproximal portion of the surgical tool. The needle receptacle and thesuture package may be supported on opposite sides of the surgical tool.The suture package holder and the needle receptacle may be supported ona same side of the surgical tool. The coupling may comprise a toolattachment pocket and the proximal portion of the surgical tool may beplaced in the tool attachment pocket. The tool attachment pocket may becoupled to the surgical tool with an adhesive layer. The apparatus maycomprise two suture packages coupled to the proximal portion of thesurgical tool. The needle receptacle may be sandwiched between the twosuture packages.

In many embodiments, the apparatus further comprises a tool holdermounted on the support for holding a needle driver.

In many embodiments, the apparatus further comprises a tool holdermounted on the support for holding scissors.

In many embodiments, the needle receptacle is configured to contain bothends of a dispensed suture needle placed into the needle receptacle.

In many embodiments, the needle receptacle comprises a mechanism thatcompresses a component of the needle receptacle against a tip of adispensed suture needle placed into the needle receptacle.

In many embodiments, the needle receptacle comprises a tapered structurethat guides a tip of a dispensed suture needle into the needlereceptacle.

In many embodiments, the needle receptacle comprises a tapered structurethat guides a portion of a dispensed suture needle into the needlereceptacle.

In many embodiments, the portion of the dispensed suture needle is a tipof the needle.

In many embodiments, the needle receptacle comprises a foam materialshaped to contact a tip of a dispensed suture needle placed into theneedle receptacle.

In many embodiments, the needle receptacle comprises a door coupled to alever for opening and closing the door.

In many embodiments, the needle receptacle weighs less than 45 grams.

In many embodiments, the needle receptacle comprises a plurality ofchannels for storing the plurality of dispensed suture needles. Theneedle receptacle may further comprise a power source, a first conductorelectrically coupled to the power source, and a first visual indicatorelectrically coupled between the power source and a second conductor.The first visual indicator may indicate the presence of a firstdispensed suture needle in a first channel of the plurality of channelswhen the first dispensed suture needle is placed in contact with boththe first conductor and the second conductor. The power source maycomprise a battery. The first visual indicator may comprise a firstlight. The needle receptacle may further comprises a second visualindicator electrically coupled between the power source and a thirdconductor. The second visual indicator may indicate the presence of asecond used needle in a second channel of the plurality of channels whenthe second used needle is placed in contact with both the secondconductor and the third conductor. The second visual indicator maycomprise a second light. The needle receptacle may further comprisenumerical markings for the plurality of channels.

In many embodiments, the needle receptacle is configured to renderinnocuous both ends of the suture needle when placed in the receptacle.The needle receptacle may comprise a structure to view the needle withboth ends rendered innocuous.

In many embodiments, the needle receptacle is configured to receive thesuture needle and to stabilize the surgical needle within the needlereceptacle on a needle receptacle support. The needle receptacle supportmay comprise one or more of a magnet, an adhesive, or a deflectablematerial to stabilize the suture needle.

In many embodiments, the needle receptacle is configured to receive thesuture needle with sliding movement and corresponding resistance to thesliding movement in order to stabilize the surgical needle within theneedle receptacle.

In many embodiments, the needle receptacle comprises a transparent coverto view a plurality of suture needles rendered innocuous therein. Theneedle receptacle may comprise an opening to place the plurality ofsuture needles within the suture needle receptacle.

In many embodiments, the needle receptacle comprises a structured arrayto arrange a plurality of needles along the array for counting.

Aspects of the present disclosure may provide methods for securing of asuture needle by a surgeon. A suture needle may be inserted into anopening of a needle receptacle with a needle driver. The suture needlemay be rotated inside the needle receptacle to insert an end of theneedle into a material. The suture needle may be released from theneedle driver. With the inserting step, the needle may be translatedaway from a leading end. With the rotating step, a trailing end of theneedle may be inserted into the deformable structure. The material maycomprise one or more of a deformable material, an adhesive material oran elastic material. The material may comprise one or more of a foam,elastic membrane, or an adhesive.

Aspects of the present disclosure provide methods for securing of asuture needle by a surgeon. A suture needle may be inserted into anopening of a needle receptacle with a needle driver. The suture needlemay be secured inside the needle receptacle. The suture needle may bereleased from the needle driver. The needle receptacle may be configuredto store a plurality of suture needles.

In many embodiments, the needle receptacle is located within a nearsurgical field.

In many embodiments, the needle receptacle comprises an entry zone and asecure zone. The inserting step may comprise placing the suture needleon the entry zone of the needle receptacle. The securing step maycomprise sliding the suture needle from the entry zone into a needleslot in the secure zone.

In many embodiments, the needle receptacle is coupled to a second needlereceptacle. The method may further comprise steps of placing a secondsuture needle on a second entry zone of the second needle receptacle,and sliding the second suture needle from the second entry zone into asecond secure zone of the second needle receptacle.

In many embodiments, the secure zone comprises a needle driver slot andthe inserting step comprises moving a distal portion of the needledriver along the needle driver slot to place the suture needle in thesecure zone.

In many embodiments, the secure zone comprises a compressive member thatcompresses against at least a portion of the suture needle during thesecuring step.

In many embodiments, the secure zone comprises a compressive member thatapplies a force against at least a portion of the suture needle duringthe securing step.

In many embodiments, secure zone comprises a plurality of protrusionsthat extend into the needle slot. The securing step may comprise movingthe suture needle against a plurality of protrusions in the secure zone.

In many embodiments, the method may further comprise steps of detectingthe suture needle placed into the needle receptacle, determining anumber of suture needles disposed within the needle receptacle, anddisplaying the number of the sutures needles disposed within the needlereceptacle on a visual display. The needle receptacle may comprise afirst conductor and a second conductor that are electrically coupled toa power source. The suture needle may be disposed within the needlereceptacle is in contact with both the first conductor and the secondconductor. The detecting step may comprise measuring an electricalcurrent through the first conductor and the second conductor.

In many embodiments, securing step may comprises a step of rotating afirst suture needle within the needle receptacle so that an end of thesuture needle is pressed into a first surface of a first structuremounted to the needle receptacle. The first structure may comprise oneor more of a deformable material, an adhesive material or elasticstructure, the first structure comprising one or more of a foam, elasticmembrane, or an adhesive. The needle receptacle may comprise an offsetzone between the opening and the first structure. During the insertionstep, the first suture needle may be moved through the offset zonebefore performing the rotating step. The method may further comprisesteps of inserting a second suture needle through the opening of theneedle receptacle with the needle driver and rotating the second sutureneedle within the needle receptacle so that an end of the second sutureneedle is pressed into a second surface of the first structure mountedto the needle receptacle. The first suture needle may be rotated in aclockwise direction about a longitudinal axis of the needle driver. Thesecond suture needle may be rotated in a counterclockwise directionabout the longitudinal axis of the needle driver. The first structuremay comprise one or more of a foam or an adhesive or a deformablematerial.

In many embodiments, the method further comprises steps of viewing thesuture needle through a wall of the needle receptacle, wherein the wallis transparent, and counting suture needles disposed within the needlereceptacle. The needle receptacle may be mounted on a proximal portionof a surgical tool.

Aspects of the present disclosure provide needle receptacles. Anexemplary needle receptacle may comprise a lower structure, an upperstructure, a needle slot, and a needle driver slot. The lower structuremay have an entry zone and a secure zone. The upper structure may have asecure zone. The needle slot may be for receiving one or more sutureneedles between the lower structure and the upper structure. The needledriver slot may extend through a portion of the upper structure.

In many embodiments, the needle driver slot is perpendicular to theneedle slot.

In many embodiments, a long axis of the needle driver slot isperpendicular to a long axis of the needle slot.

In many embodiments, the needle driver slot extends through a portion ofthe lower structure.

In many embodiments, the needle receptacle further comprises acompressible member that is adjacent to the needle slot.

In many embodiments, the needle receptacle further comprises a pluralityof protrusions that are adjacent to the needle slot.

In many embodiments, the needle receptacle further comprises comprisinga needle counting mechanism configured to detect a number of sutureneedles disposed in the secure zone of the needle receptacle.

In many embodiments, the needle receptacle further comprises a powersource, a first conductor electrically coupled to the power source, asecond conductor electrically coupled to control circuitry, and a visualdisplay electrically coupled to the control circuitry. The visualdisplay may indicate the number of suture needles disposed in the securezone when the suture needles are placed in contact with both the firstconductive element and the second conductive element.

In many embodiments, the needle receptacle is coupled to a second needlereceptacle through a coupling in direct contact with both the needlereceptacle and the second needle receptacle. The coupling may comprise atool slot adapted to fit over a proximal end of a surgical tool.

In many embodiments, the needle receptacle further comprises a camerafor obtaining a photographic image of the suture needle in the securezone. The needle receptacle may further comprise a transmitter fortransmitting the photographic image of the suture needle to a receiver.

In many embodiments, the needle receptacle may further comprise a camerafor obtaining a photographic image for the presence of the suture needlein the secure zone. The needle receptacle may further comprise atransmitter for transmitting the photographic image for the presence ofthe suture needle to a receiver.

Another exemplary needle receptacle may comprise a housing having anopening and an interior volume and a first elongated member coupled toan interior surface of the housing. The first elongated member may havea needle insertion surface that extends inward from the interior surfaceof the housing.

In many embodiments, the first member comprises one or more of adeformable material, an adhesive material, or elastic structure. Thedeformable material may comprise one or more of a foam, elasticmembrane, or an adhesive. The interior volume may be substantiallycylindrical. The first deformable member may extend from the interiorsurface substantially radially inward into the interior volume.

In many embodiments, the needle receptacle may further comprise a secondelongated member coupled to the interior surface of the housing. Thefirst member and the second deformable member may be on opposite sidesof the interior surface of the housing. The second member may compriseone or more of a deformable material, an adhesive material, or elasticstructure. The first member may comprise one or more of a foam, elasticmembrane, or an adhesive.

In many embodiments, the opening comprises an elongated slot that islonger than a length of the needle.

In many embodiments, the housing is transparent.

Aspects of the present disclosure provide apparatuses for protecting alimb of a surgeon from contact with a needle. An exemplary apparatus maycomprise a barrier having a curved cross section and a coupling tocouple the barrier to the limb of the surgeon. The barrier may beconfigured to support one or more of a suture package or a needlereceptacle.

In many embodiments, the apparatus further comprises a barrier mount.The barrier mounting base may be configured to support one or more of asuture package or a needle receptacle. The barrier may be configured tosupport the barrier mount.

In many embodiments, the barrier comprises a sterile barrier and thecoupling comprises a sterile coupling.

In many embodiments, the barrier comprises an extension sized to extendover a dorsal side of a hand of a surgeon. The extension may comprise astiffness to support one or more of a suture package or a needlereceptacle.

In many embodiments, the barrier comprises an extension sized to extendover a dorsum of a hand of a surgeon. The extension may comprise adeflection to allow movement of the hand to a dorsal radial side of thesurgeon.

In many embodiments, the barrier comprises an extension sized to extendover a hand of a surgeon.

In many embodiments, the coupling comprises one or more of a first legor a second leg.

In many embodiments, the coupling comprises a first leg and a secondleg. The first leg may extend outward from a distal portion of thebarrier in a first direction. The second leg may extend outward from thedistal portion of the barrier in a second direction that is opposite tothe first direction.

In many embodiments, the coupling comprises a plurality of proximallegs.

In many embodiments, the coupling comprises one or more slap bracelets.

In many embodiments, the coupling comprises a strap configured to wraparound a portion of a forearm of the surgeon. The strap may be coupledto opposite edges of the barrier.

In many embodiments, the coupling comprises a thumb loop disposed on adistal portion of the barrier. The thumb loop may be configured tocouple to a thumb of the surgeon. The thumb loop may be made of aflexible material. The thumb loop may be formed in the barrier.

In many embodiments, the barrier may comprise a malleable materialconfigured to deform to curve around the limb. The barrier may comprisea plurality of grooves extending in a parallel to a length of the limb.The barrier may comprise an inner foam layer configured to be compressedagainst the limb. The barrier may be configured to support a needlereceptacle on a volar portion of the barrier. The barrier may beconfigured to support a suture package with one or more of a volar or aradial portion of the barrier. The dorsal portion of the barrier maycomprise a tool holder.

In many embodiments, the barrier comprises the curved cross section in afree standing configuration.

In many embodiments, the barrier comprises a curved thermoformed barriermaterial.

Aspects of the present disclosure may provide a method comprising thesteps of providing a needle receptacle comprising a housing having aneedle slot and a needle driver slot wherein the needle driver slotintersects a side portion of the needle slot, grasping an end portion ofa suture needle with a needle driver, moving the suture needle along theneedle slot by sliding the needle driver along the needle slot, andreleasing the suture needle within the needle slot.

In many embodiments, the needle driver moves through the needle driverslot in a straight path or a spiral path.

In many embodiments, the needle driver moves through the needle driverslot in a circular path.

In many embodiments, the method further comprises steps of providing acompressive member adjacent to the needle slot and compressing thecompressive member against the needle.

In many embodiments, the method further comprises steps of applying arotational torque about a center axis to the needle driver.

In many embodiments, the method further comprises steps of viewing theend portion of the needle within the needle driver slot and determininga number of the needles within the needle receptacle based upon theviewing step.

In many embodiments, the method further comprises steps of detecting thesuture needle placed into the needle slot, determining a number of theneedles within the needle receptacle, and displaying the number of theneedles within the needle receptacle on a visual display.

In many embodiments, the method further comprises steps of providing abarrier and coupling the needle receptacle to the barrier.

In many embodiments, the barrier is adapted to be placed on a limb of asurgeon.

In many embodiments, the coupling of the needle receptacle to thebarrier is via a magnetic coupling or a hook and loop coupling.

In many embodiments, the method further comprises steps of providing oneor more straps that extend from the barrier. The straps may be adaptedto secure the barrier to a limb of a surgeon.

Aspects of the present invention may provide needle receptacles. Anexemplary needle receptacle may comprise a housing, a needle slot, afirst needle driver slot, and a second needle driver slot. The housingmay have a cross section having a width and a thickness. The needle slotmay be for storing used suture needles within the cross section of thehousing. The first needle driver slot may extend through the thicknessof the housing. The first needle driver slot may intersect a sideportion of the needle slot. The needle driver slot may extend through aportion of the upper structure.

In many embodiments, the needle driver slot is substantiallyperpendicular to the needle slot.

In many embodiments, the needle driver slot has a circular portion or aspiral portion.

In many embodiments, the needle receptacle further a compressible memberthat is adjacent to the needle slot.

In many embodiments, the needle receptacle further comprises a needlecounting mechanism for detecting a number of needles in the needlereceptacle. The needle receptacle may further comprise a power sourceand a visual display electrically coupled to needle counting circuitry.The visual display may indicate a number of needles in the needlereceptacle.

In many embodiments, the needle receptacle further comprises a barrier,and the needle receptacle is attached to the barrier. The needlereceptacle may further comprise a suture pack holder for holding suturepacks attached to the barrier. The needle receptacle may furthercomprise one or more straps that extend from side of the barrier adaptedto secure the barrier to a limb of a surgeon.

Aspects of the present disclosure may provide an apparatus for handlingsuture needles, the apparatus comprising a support configured to receivea suture package and a needle receptacle.

Aspects of the present disclosure may provide an apparatus for handlingsuture needles, the apparatus comprising a platform to attach a suturepackage and a used needle holder.

Aspects of the present disclosure may provide an apparatus for handlingsuture needles, the apparatus comprising a platform to attach a suturepackage and a used needle receptacle.

Aspects of the present disclosure may provide an apparatus for receivinga plurality of contaminated surgical suture needles, each needle havinga tip, a trailing end and a needle body extending between the tip andthe trailing end. The apparatus may comprise a housing having a top anda bottom, at least one opening between the top and the bottom configuredand dimensioned to receive a contaminated surgical needle insertedtherethrough, a window, and an innocuous zone within the housing to holdthe plurality of contaminated surgical needles in an arrangement forcounting through the window with each tip and trailing end.

Aspects of the present disclosure may provide an apparatus for receivinga contaminated surgical suture needle, the needle having a tip, atrailing end and a needle body extending between the tip and thetrailing end. The apparatus may comprise a housing having a top and abottom, at least one opening between the top and the bottom configuredand dimensioned to receive a contaminated surgical needle insertedtherethrough, and a secure zone within the housing to hold thecontaminated surgical needle in an orientation with the needle tipsecured.

In many embodiments, the orientation comprises a predeterminedorientation.

In many embodiments, the at least one opening is configured anddimensioned to receive the contaminated surgical needle in a lateralorientation.

In many embodiments, wherein the at least one opening is configured anddimensioned to receive the contaminated surgical needle in a transverseorientation.

In many embodiments, the surgical needle is a curved needle and at leasta portion of the curved needle body enters the opening before the tip orthe trailing end thereof.

In many embodiments, the apparatus further comprises a first sideconnected to and extending between the top and the bottom, a second sideconnected to and extending between the top and the bottom, a first end,and a second end. The at least one opening may be disposed in the firstend.

In many embodiments, the top and bottom are circular in shape.

In many embodiments, the secure zone is configured and dimensioned toreceive a plurality of contaminated surgical needles.

In many embodiments, at least a portion of the top is sufficientlytransparent to permit visualization of contaminated needles disposed inthe secure zone.

In many embodiments, the apparatus includes a window permittinginspection and counting of a plurality of contaminated surgical needlescontained therein. The plurality of contaminated surgical needles maycomprise at least five surgical needles.

In many embodiments, the housing top includes a slot configured anddimensioned to receive a tip of a needle driver, facilitating insertionof the contaminated surgical needle into the housing under control ofthe needle driver.

In some embodiments, the slot is offset to view a trailing end of theneedle.

In some embodiments, the slot is linear.

In some embodiments, the slot is curved.

In some embodiments, the slot is straight and is oriented along thecenter of the top.

In some embodiments, the slot is straight and is oriented off thelongitudinal axis of the top.

In some embodiments, the apparatus comprises a plurality of slots.

In some embodiments, the slot is configured and dimensioned to orientthe needle driver into a specific orientation relative to the slot.

In many embodiments, the secure zone includes needle retention featuresto hold a plurality of contaminated surgical needles in a predeterminedorientation.

In many embodiments, the apparatus further comprises needle retentionfeatures to hold the contaminated surgical needle between the top andbottom. The needle retention features may comprise foam disposed betweenthe top and bottom, such as urethane foam.

In some embodiments, the needle retention features comprise loop andhook fasteners disposed between the top and bottom.

In some embodiments, the needle retention features comprise a pluralityof protrusions extending from one or both of the top and bottom. Theplurality of protrusions may comprise dimples, protuberances, orfilaments. The plurality of protrusions may be angled away from the atleast one opening to permit the needle to pass into the secure zone andto resist movement of the needle toward the at least one opening. Theneedle retention features may comprise flaps disposed between the topand bottom.

In some embodiments, the needle retention features comprise gel disposedbetween the top and bottom.

In some embodiments, the needle retention features comprisehemispherical nubs disposed between the top and bottom.

In some embodiments, the needle retention features comprise angledbristles disposed between the top and bottom.

In many embodiments, the apparatus further includes a sterile mountingmember attached to the housing for mounting the apparatus in the nearsurgical field.

In many embodiments, the top and bottom are injection molded.

In many embodiments, the top and bottom snap fit together.

In many embodiments, the top and bottom are welded together, such asultrasonically welded together.

In many embodiments, the top and bottom are adhesively connected.

In many embodiments, the top surface is comprised of clearpolycarbonate.

In many embodiments, the top and bottom are comprised of polycarbonate.

In many embodiments, the apparatus further comprises a slot through thetop surface.

In many embodiments, the top and bottom are flexible.

In many embodiments, the top and bottom are rigid.

In many embodiments, one or both of the top and bottom define an entryzone, a transition zone, and a secure zone. The entry zone may define alanding zone which is wider than the entry zone to facilitate movementof the needle toward the entry zone. The entry zone may include at leastone structure to urge a needle driver holding a contaminate needletoward a slot in the top surface. The structure may include a V-shapedentry edge of the entry zone.

In many embodiments, the apparatus may further comprise a sterilepackage containing the apparatus.

In many embodiments, the apparatus may further include a sterilemounting member attached to the housing for mounting the apparatus inthe near surgical field. The mounting apparatus may comprises a barrierconfigured and dimensioned to be mounted to a forearm of a surgeon. Thebarrier may be configured and dimensioned to support a sterile packageof surgical needles and sutures.

In many embodiments, the innocuous zone within the housing is configuredto hold the plurality of contaminated surgical needles in an arrangementfor counting through the window with either of each tip and trailing endbeneath the window.

Aspects of the present disclosure may provide an apparatus comprisingone or more of a sterile surgical gown, a sterile glove, or a sterilecover configured with a barrier to inhibit needle sticks and a surfaceconfigured to stably support one or more of a suture pack or a needlereceptacle over one or more of a hand, a radial forearm or a volarforearm.

Aspects of the present disclosure may provide an apparatus comprisingone or more of a sterile surgical gown, a sterile glove, or a sterilecover configured with a barrier to inhibit needle sticks and a surfaceconfigured to stably support one or more of a suture pack or a needlereceptacle over one or more of a hand, a radial forearm, a volarforearm, a dorsal forearm, a ulnar forearm, and wrist.

Aspects of the present disclosure may provide an apparatus comprisingone or more of a sterile cover or a sterile drape configured with abarrier to inhibit needle sticks and a surface configured to stablysupport one or more of a suture pack or a needle receptacle in a nearsurgical field.

Aspects of the present disclosure may provide a surgical suturing kitcomprising a sterile enclosure that may contain a sterile package ofsterile sutures and a sterile apparatus for receiving at least onecontaminated surgical suture needle.

Aspects of the present disclosure may provide a surgical suturing kitcomprising a sterile enclosure that may contain a sterile package ofsterile sutures and a sterile apparatus for receiving at least onecontaminated surgical suture needle. The needle may have a tip, atrailing end, and a needle body extending between the tip and thetrailing end. The sterile apparatus may comprise a sterile housinghaving a top and a bottom, at least one opening between the top and thebottom configured and dimensioned to receive a contaminated surgicalneedle inserted therethrough, and a secure zone within the housing tohold the contaminated surgical needle in a predetermined orientationwith the needle tip secured.

The surgical kit may further comprise a barrier configured anddimensioned to support the package of sterile sutures and the apparatusfor receiving the at least one contaminated surgical suture needle.

The barrier layer may be configured and dimensioned to be mounted to aforearm of a surgeon.

Aspects of the present disclosure may provide a method comprising a stepof placing a needle in a used needle holder.

Aspects of the present disclosure may provide an apparatus comprising aused needle holder.

Aspects of the present disclosure may provide an apparatus comprisingmeans for securing a used needle.

Aspects of the present disclosure may provide an apparatus for handlingsutures, comprising a sterile housing, a suture dispensing portiondisposed within the housing, the suture dispensing portion configured tosupport one or more sterile suture needles, and a needle receptacleportion disposed within the housing, the needle receptacle portionconfigured to secure a plurality of dispensed suture needles.

Aspects of the present disclosure may provide an apparatus comprisingneedle receptacle means for stabilizing and rendering innocuous adispensed needle.

Aspects of the present disclosure may provide an apparatus comprisingneedle receptacle means for stabilizing and rendering innocuous adispensed needle and barrier means for supporting the needle receptaclemeans in order to place dispensed needles in the needle receptaclemeans.

Aspects of the present disclosure may provide an apparatus comprisingneedle receptacle means for stabilizing and rendering innocuous adispensed needle and a barrier means for supporting the needlereceptacle means in order to place dispensed needles in the needlereceptacle means.

Aspects of the present disclosure may provide an apparatus for use in asterile operating room. The apparatus may comprise a dispensed needlereceptacle, a suture package, and a barrier to support one or more ofthe dispensed needle receptacle or the suture package and inhibit needlepenetration through the barrier. The dispensed needle receptacle, thesuture package, and the barrier may be arranged within a near surgicalfield of a surgeon.

The apparatus may comprise a barrier mounting base to support one ormore of the dispensed needle receptacle or the suture package andinhibit needle penetration through the barrier. The barrier may be tosupport the barrier mounting base.

Aspects of the present disclosure may an apparatus for use in a sterileoperating room comprising a dispensed needle receptacle comprising fiveor more dispensed surgical needles. The dispensed surgical needles maybe stabilized and innocuous within the needle receptacle. The needlereceptacle may comprise one or more of an opening, a window, or atransparent material for counting the stabilized innocuous dispensedneedles. The needles may be arranged for counting within the receptacle.

Aspects of the present disclosure may provide a method of securingdispensed needles, comprising a step of receiving a dispensed needlereceptacle comprising five or more dispensed surgical needles from aneutral zone. The dispensed surgical needles may be stabilized andinnocuous within the needle receptacle. The needle receptacle maycomprise one or more of an opening, a window, or a transparent materialfor counting the stabilized innocuous dispensed needles. The needles maybe arranged for counting within the receptacle.

Aspects of the present disclosure may provide a method of securingdispensed needles comprising a step of receiving a dispensed needlereceptacle comprising five or more dispensed suture needles from aneutral zone. The dispensed surgical needles may be stabilized andinnocuous within the needle receptacle. The needle receptacle maycomprise one or more of an opening, a window, or a transparent materialfor counting the stabilized innocuous dispensed needles. The needles maybe arranged for counting within the receptacle.

Aspects of the present disclosure may provide a method of securingdispensed needles comprising a step of receiving a dispensed needlereceptacle comprising five or more dispensed suture needles from a nearsurgical field. The dispensed surgical needles may be stabilized andinnocuous within the needle receptacle. The needle receptacle maycomprise one or more of an opening, a window, or a transparent materialfor counting the stabilized innocuous dispensed needles. The needles maybe arranged for counting within the receptacle.

Aspects of the present disclosure may provide a method of securingdispensed needles comprising steps of inserting a suture needle into anopening of a needle receptacle with a needle driver and releasing thedispensed needle from the needle driver. The needle receptacle may beconfigured to store a plurality of five or more dispensed needles. Thedispensed needle may be stabilized, innocuous, and arranged with four ormore stabilized innocuous dispensed needles for counting in thecontainer though one or more of a channel, an opening, a window, or atransparent material.

Aspects of the present disclosure may provide an apparatus for handlingneedles. The apparatus may comprise a suture package configured todispense a plurality of needles, a needle receptacle configured to storea plurality of dispensed needles, and a support configured to supportone or more of the suture package or the needle receptacle.

Aspects of the present disclosure may provide a method for handlingsuture needles. The method may comprise steps of grasping a needle witha needle driver to dispense the needle from a suture package mounted ona support and placing the dispensed needle into a needle receptaclemounted on the support.

The apparatuses or method disclosed herein may comprise a barriercomprising a weight of no more than about 6 ounces (170 grams) and aneedle receptacle comprising a capacity of at least about 5 needles, anoverall thickness of no more than about 0.5 inches (12.5 mm), a lengthof no more than about 5″ (127 mm), and a width of no more than about2.5″ (63.5 mm) to receive and store the at least about 8 needles in alinear array.

The apparatuses or method disclosed herein may comprise a barriercomprising a weight of no more than about 6 ounces (170 grams) and aneedle receptacle comprising a capacity of at least about 5 needles, anoverall thickness of no more than about 0.5 inches (12.5 mm), a lengthof no more than about 5″ (127 mm), and a width of no more than about2.5″ (63.5 mm) to receive and store the at least about 5 needles in alinear array or an arcuate array.

The apparatuses or method disclosed herein may comprise a barriercomprising a weight of no more than about 6 ounces (170 grams) and aneedle receptacle comprising a capacity of at least about 8 needles, anoverall thickness of no more than about 0.5 inches (12.5 mm), a lengthof no more than about 5″ (127 mm), and a width of no more than about 4″(101.6 mm) to receive and store the at least about 8 needles in anarcuate array.

The apparatuses or method disclosed herein may comprise a barriercomprising a weight of no more than about 6 ounces (170 grams) and aneedle receptacle comprising a capacity of at least about 8 needles, anoverall thickness of no more than about 0.5 inches (12.5 mm), a lengthof no more than about 5″ (127 mm), and a width of no more than about 4″(101.6 mm) to receive and store the at least about 8 needles in a lineararray.

In the apparatuses, methods, and needle receptacle disclosed herein, theneedle receptacle may comprise a channel having an elongate crosssection sized to receive a plurality of suture needles in an orderedarray and a slot extending into the channel to receive a needle driverand advance a suture needle of the plurality along the channel forplacement among the plurality of needles of the ordered array.

The apparatuses, methods, and needle receptacle disclosed herein mayfurther comprise one or more of a sterile surgical gown, a sterileglove, or a sterile cover configured with a barrier to inhibit needlesticks and a surface configured to stably support one or more of asuture pack or a needle receptacle over one or more of a hand, a radialforearm or a volar forearm.

In the apparatuses, methods, and needle receptacle disclosed herein, oneor more of a sterile cover or a sterile drape may be configured with abarrier to inhibit needle sticks and a surface configured to stablysupport one or more of a suture pack or a needle receptacle.

The apparatuses, methods, and needle receptacle disclosed herein mayenable passing of a plurality of suture needles into and out of a nearsurgical field, thereby eliminating passing of individual suture needlesbetween a surgeon and a surgical assistant.

The apparatuses, methods, and needle receptacle disclosed herein mayenable passing of a plurality of secured into and out of a near surgicalfield, thereby eliminating passing of individual suture needles betweena surgeon and a surgical assistant.

The apparatuses, methods, and needle receptacle disclosed herein mayenable passing of a plurality of innocuous needles into and out of anear surgical field, thereby eliminating passing of individual sutureneedles between a surgeon and a surgical assistant.

The apparatuses, methods, and needle receptacle disclosed herein mayenable passing of a plurality of used needles into and out of a nearsurgical field, thereby eliminating passing of individual suture needlesbetween a surgeon and a surgical assistant.

The apparatuses, methods, and needle receptacle disclosed herein maycomprise a step of dispensing of a suture needle by a surgeon from anear surgical field.

The apparatuses, methods, and needle receptacle disclosed herein maycomprise a means for mounting one or more suture needle packages withina near surgical field.

The apparatuses, methods, and needle receptacle disclosed herein maycomprise a needle resistant barrier mounted on a surgeon's arm. Theneedle resistant barrier may be configured to provide a mounting surfacefor one or more suture needle packages.

In the apparatuses, methods, and needle receptacle disclosed herein, aneedle resistant barrier may comprise a light weight material and may beconfigured to conform to one or more of a surgeons arm, wrist, or hand.

In the apparatuses, methods, and needle receptacle disclosed herein, aneedle resistant barrier may comprise a thin, puncture-resistantmaterial integrated with a flexible web.

In the apparatuses, methods, and needle receptacle disclosed herein, aneedle resistant barrier may be configured to adjust in order toaccommodate a range of forearm sizes.

In the apparatuses, methods, and needle receptacle disclosed herein, aneedle resistant barrier may comprise a plurality of bi-stable springsconnected by a flexible web.

In the apparatuses, methods, and needle receptacle disclosed herein, aneedle resistant barrier may comprise a malleable metal material havingone or more grooves to control bending of the malleable metal material.

In the apparatuses, methods, and needle receptacle disclosed herein, aneedle resistant barrier may comprise a plastic material having one ormore hinges.

In the apparatuses, methods, and needle receptacle disclosed herein, aneedle resistant barrier may be configured to be donned and doffedquickly with one hand.

In the apparatuses, methods, and needle receptacle disclosed herein, aneedle resistant barrier may comprise a plurality of stacked bi-stablesprings to adjust a compressive force.

In the apparatuses, methods, and needle receptacle disclosed herein, aneedle resistant barrier may be configured to provide a modular mountingsurface on a dorsal side of one or more of a forearm or a wrist. Themodular mounting surface may be configured to support one or moresurgical tools or materials.

In the apparatuses, methods, and needle receptacle disclosed herein, asuture needle package may be configured to mount on one or more of asurgeon's arm, wrist, or a back of a hand.

In the apparatuses, methods, and needle receptacle disclosed herein, asuture needle package may be configured to mount on the needlereceptacle.

In the apparatuses, methods, and needle receptacle disclosed herein, aneedle resistant barrier may be configured to provide protection to avolar side of one or more of a forearm or a wrist.

In the apparatuses, methods, and needle receptacle disclosed herein, theneedle receptacle may be configured to couple to a surgical drape.

In the apparatuses, methods, and needle receptacle disclosed herein, theneedle receptacle may be configured to couple to a needle resistantbarrier mounted on a surgeon's forearm.

In the apparatuses, methods, and needle receptacle disclosed herein, theneedle receptacle may be configured to attach and detach from a needleresistant barrier with one hand.

In the apparatuses, methods, and needle receptacle disclosed herein, theneedle receptacle may be configured to attach to a surgical tool

In the apparatuses, methods, and needle receptacle disclosed herein, theneedle receptacle may be configured to attach to a surgical tool, andthe needle receptacle may be configured to accommodate a variety ofhandle widths and thicknesses of a surgical tool.

In the apparatuses, methods, and needle receptacle disclosed herein, theneedle receptacle may be configured to couple to a needle resistantbarrier integrated into a surgical apparel.

In the apparatuses, methods, and needle receptacle disclosed herein, theneedle receptacle may be configured to couple to a needle resistantbarrier integrated into a surgical gown, a gown sleeve, or an extendedglove.

In the apparatuses, methods, and needle receptacle disclosed herein, theneedle receptacle may be configured to provide protection from bothleading and trailing ends of a plurality of used suture needles by oneor more of encapsulating or covering.

In the apparatuses, methods, and needle receptacle disclosed herein, theneedle receptacle may be configured to inhibit one or more ofunintentional removal or dislodgment.

In the apparatuses, methods, and needle receptacle disclosed herein, theneedle receptacle may be configured to facilitate needle insertion intothe needle receptacle by allowing needles to be inserted with minimalhand-eye precision.

In the apparatuses, methods, and needle receptacle disclosed herein, theneedle receptacle may be configured to facilitate needle insertion intothe needle receptacle by allowing needles to be inserted with grossmotor movement.

In the apparatuses, methods, and needle receptacle disclosed herein, theneedle receptacle may be configured to facilitate needle insertion intothe needle receptacle by allowing needles to be inserted with onlyarticulation or rotation of the shoulder and elbow joints.

In the apparatuses, methods, and needle receptacle disclosed herein, theneedle receptacle may comprise means for counting needles during andafter the procedure.

In the apparatuses, methods, and needle receptacle disclosed herein, theneedle receptacle may comprise means for reconciling needles during orafter the procedure.

In the methods disclosed herein, a first set of needles from a firstsuture pack may be reconciled before a second suture pack enters thenear surgical field.

In the apparatuses, methods, and needle receptacle disclosed herein, theneedle receptacle is low-profile and lightweight.

In the apparatuses, methods, and needle receptacle disclosed herein theneedle receptacle may be configured to receive needles held in needledrivers in various positions.

In the apparatuses, methods, and needle receptacle disclosed herein theneedle receptacle may be is configured to inhibit magnetizing the needledriver.

In the apparatuses, methods, and needle receptacle disclosed herein theneedle receptacle may be is configured to receive at least about 5needles.

The apparatuses, methods, and needle receptacle disclosed herein mayfurther comprise a step of cutting of a suture by a surgeon using acutter disposed in a near surgical field.

In the apparatuses, methods, and needle receptacle disclosed herein, acutter may be mounted on a surgeon's finger.

In the apparatuses, methods, and needle receptacle disclosed herein, acutter may be mounted on a needle resistant barrier.

In the apparatuses, methods, and needle receptacle disclosed herein, acutter may comprise retractable scissors on a cable with take up spool.

In the apparatuses, methods, and needle receptacle disclosed herein, acutter may comprise an integrated and recessed blade.

In the apparatuses, methods, and needle receptacle disclosed herein, acutter may be mounted on a surgical tool.

In the apparatuses, methods, and needle receptacle disclosed herein, acutter may comprise may be integrated with a needle receptacle.

In the apparatuses, methods, and needle receptacle disclosed herein, acutter may comprise may be configured to prevent unintentional damage toa surgeon's glove.

In the apparatuses, methods, and needle receptacle disclosed herein, theneedle receptacle may be arranged over the volar forearm to allow easyinsertion of a used needle when a hand holding needle holder is slightlypronated. The needle may be placed in the receptacle with rotation of anarm holding a needle driver with shoulder joint rotation in order toalign and place the used needle into an opening of the needlereceptacle. The needle may comprise a curved needle having a tip and atail, and the length may be defined as a straight-line distance betweenthe tip and the tail.

In many embodiments of the barrier, curved shell conforms to the shapeof a volar surface of the forearm.

In many embodiments of the barrier, the curvature of the curved shellextending with curvature about the longitudinal axis conforms to a shapeof a volar surface of the forearm.

In many embodiments of the barrier, the pre-formed shaped barrierconforms to the shape of a volar surface of the forearm.

In many embodiments of the barrier, the pre-formed shaped barrier isstraight along the dorsal edge.

In many embodiments of the barrier, the curved shell is straight alongthe dorsal edge.

Aspects of the present disclosure may provide needle receptacles. Anexemplary needle receptacle may comprise a lower structure and an upperstructure above the lower structure to define a needle slot between theupper structure and the lower structure. The needle slot may comprise asecure zone to secure needles. The upper structure may comprise a firstedge and a second edge arranged to define a deformable needle driverslit that extends through a portion of the upper structure, wherein theslit deforms to receive a needle driver.

Another exemplary needle receptacle may comprise a housing having across section having a width and a thickness, a needle slot for storingused suture needles within the cross section of the housing, and adeformable needle driver slot that extends through a portion of theupper structure.

Another exemplary needle receptacle may be for receiving a surgicalsuture needle, the needle having a tip, a trailing end and a needle bodyextending between the tip and the trailing end. The needle receptaclemay comprise a housing, at least one opening, a secure zone, and adeformable driver needle slit. The housing may have a top and a bottom.The at least one opening between the top and the bottom may beconfigured and dimensioned to receive a surgical needle therethough. Thesecure zone within the housing may be configured to hold the surgicalneedle in an orientation with the needle tip secured. The secure zonemay be in communication with the opening. The deformable needle driverslit may extend through the top of the housing and within the securezone.

In many embodiments, the first edge separates from the first edge toreceive the needle driver.

In many embodiments, the deformable needle driver slit includes a firstedge and a second edge opposite the first edge.

In many embodiments, the first edge and the second edge contact eachother in a non-deformed free standing state without a needle driverextending therebetween.

In many embodiments, the first edge and the second edge are spaced apartfrom each other in a non-deformed state, with a gap being definedbetween the first edge and the second edge.

In some embodiments, the gap is less than 1 mm.

In some embodiments, the gap is less than 2 mm.

In some embodiments, the gap is less than 0.5 mm.

In some embodiments, the upper structure comprises a stiff portion and adeformable portion, with the deformable portion being proximate to andincluding the needle driver slit.

In some embodiments, the upper structure is deformable.

In some embodiments, the lower structure is deformable.

In some embodiments, the upper structure and lower structure are bothdeformable.

In some embodiments, the lower structure comprises a landing zone, andthe upper and lower structures define an entry zone and a second zone,the entry zone located between the landing zone and the secure zone andwherein separation of the slit increases proximate a needle driver whenthe needle driver advances along the slit.

In many embodiments of the apparatuses, methods, and needle receptaclesdisclosed herein, a portion of a needle body is visible through theneedle driver slot.

In many embodiments of the apparatuses, methods, and needle receptaclesdisclosed herein, a mid-body portion a needle body is visible throughthe needle driver slot.

In many embodiments of the apparatuses, methods, and needle receptaclesdisclosed herein, a portion of a needle body is visible through theneedle driver slot in the upper structure.

In many embodiments of the apparatuses, methods, and needle receptaclesdisclosed herein, a mid-body portion a needle body is visible throughthe needle driver slot visible through the needle driver slot in theupper structure.

In many embodiments of the apparatuses, methods, and needle receptaclesdisclosed herein, a portion of a needle body is visible through theneedle driver slot in the lower structure.

In many embodiments of the apparatuses, methods, and needle receptaclesdisclosed herein, a mid-body portion a needle body is visible throughthe needle driver slot visible through the needle driver slot in thelower structure.

In many embodiments of the apparatuses, methods, and needle receptaclesdisclosed herein, a portion of a needle body is visible through both theneedle driver slot in the lower structure and the needle driver slot inthe upper structure.

In many embodiments of the apparatuses, methods, and needle receptaclesdisclosed herein, a mid-body portion a needle body is visible throughthe needle driver slot visible through both the needle driver slot inthe lower structure and the needle driver slot in the upper structure.

In many embodiments of the apparatuses, methods, and needle receptaclesdisclosed herein, the lower structure provides for non-uniform lighttransmission therethrough.

In many embodiments of the apparatuses, methods, and needle receptaclesdisclosed herein, the lower structure comprises a translucent material.

In many embodiments of the apparatuses, methods, and needle receptaclesdisclosed herein, the lower structure comprises a light scatteringmaterial selected from the group consisting of a translucent material, adiffuse material, a rough material, and light scattering particles.

In many embodiments of the apparatuses, methods, and needle receptaclesdisclosed herein, the lower structure is semi opaque.

In many embodiments of the apparatuses, methods, and needle receptaclesdisclosed herein, the lower structure is opaque.

In many embodiments, the apparatuses, methods, and needle receptaclesdisclosed herein may be configured to non-uniformly transmit light.

In many embodiments, the apparatuses, methods, and needle receptaclesdisclosed herein may be configured to non-uniformly transmit backlightillumination.

In many embodiments, the apparatuses, methods, and needle receptaclesdisclosed herein may be configured to diffuse light from backlightillumination in order to provide more uniform backlight illumination ofsuture needles.

In many embodiments of the apparatuses, methods, and needle receptaclesdisclosed herein, the lower structure is dyed.

In many embodiments of the apparatuses, methods, and needle receptaclesdisclosed herein, the lower structure is colored.

In many embodiments of the apparatuses, methods, and needle receptaclesdisclosed herein, the lower structure provides includes a roughenedsurface for non-uniform light transmission therethrough.

In many embodiments, the apparatuses, methods, and needle receptaclesdisclosed herein may further comprise a flap extending into or along theneedle driver slot from an edge of the needle driver slot.

In many embodiments, the apparatuses, methods, and needle receptaclesdisclosed herein may further comprise flaps extending into or along theneedle driver slot from an edge of the needle driver slot.

In many embodiments of the apparatuses, methods, and needle receptaclesdisclosed herein, the flaps are deformable.

In many embodiments of the apparatuses, methods, and needle receptaclesdisclosed herein, the needle driver slot includes a first edge and asecond edge opposite the first edge, and the flaps extend from one ofthe first and second edges.

In many embodiments of the apparatuses, methods, and needle receptaclesdisclosed herein, the needle driver slot includes a first edge and asecond edge opposite the first edge, and the flaps extend from both thefirst edge and the second edge.

In many embodiments, the apparatuses, methods, and needle receptaclesdisclosed herein may further comprise flaps extending into the needledriver slit from an edge of the needle driver slot.

In many embodiments of the apparatuses, methods, and needle receptaclesdisclosed herein, the flaps are deformable.

In many embodiments of the apparatuses, methods, and needle receptaclesdisclosed herein, the needle driver slit includes a first edge and asecond edge opposite the first edge and wherein the flaps extend fromone of the first and second edges.

In many embodiments of the apparatuses, methods, and needle receptaclesdisclosed herein, the needle driver slit includes a first edge and asecond edge opposite the first edge, and wherein the flaps extend fromboth the first edge and the second edge.

In many embodiments, the apparatuses, methods, and needle receptaclesdisclosed herein may further comprise flaps extending into the needledriver slit from an edge of the needle driver slit.

In many embodiments, the apparatuses, methods, and needle receptaclesdisclosed herein may further comprise protrusions that extend into theneedle driver slot from an edge of the needle driver slot.

In many embodiments of the apparatuses, methods, and needle receptaclesdisclosed herein, the needle driver slot includes a first edge and asecond edge opposite the first edge, and wherein the protrusions extendfrom one of the first and second edges.

In many embodiments of the apparatuses, methods, and needle receptaclesdisclosed herein, the needle driver slot includes a first edge and asecond edge opposite the first edge, and wherein the protrusions extendfrom both the first edge and the second edge.

In many embodiments, the apparatuses, methods, and needle receptaclesdisclosed herein may further comprise that extend into the needle driverslit from an edge of the needle driver slot.

In many embodiments of the apparatuses, methods, and needle receptaclesdisclosed herein, the needle driver slit includes a first edge and asecond edge opposite the first edge, and wherein the protrusion extendfrom one of the first and second edges.

In many embodiments of the apparatuses, methods, and needle receptaclesdisclosed herein, the needle driver slit includes a first edge and asecond edge opposite the first edge, and wherein the protrusions extendfrom both the first edge and the second edge.

In many embodiments, the apparatuses, methods, and needle receptaclesdisclosed herein may further comprise protrusions that extend into theneedle driver slot from an edge of the needle driver slit.

In many embodiments of the apparatuses, methods, and needle receptaclesdisclosed herein, the resistance of the needle driver along the needledriver slot is less than the resistance of the needle along the needleslot when the needle is advanced along the slot with a needle driver.

In many embodiments of the apparatuses, methods, and needle receptaclesdisclosed herein, the resistance of the needle receptacle against theneedle driver is less than the resistance of the needle receptacleagainst the needle.

In many embodiments of the apparatuses, methods, and needle receptaclesdisclosed herein, the force imparted by the needle driver slot againstmovement of the needle driver is less than the force imparted by theneedle slot against movement of the needle.

In many embodiments of the apparatuses, methods, and needle receptaclesdisclosed herein, the force imparted by the needle receptacle againstmovement of the needle driver is less than the force imparted by theneedle receptacle against movement of the needle.

In many embodiments of the apparatuses, methods, and needle receptaclesdisclosed herein, the friction force between the needle driver slot orslit and the needle driver is less than the friction force betweenneedle slot and the needle.

In many embodiments of the apparatuses, methods, and needle receptaclesdisclosed herein, the friction force between the needle receptacle andthe needle driver is less than the friction force between the needlereceptacle and the needle.

In many embodiments of the apparatuses, methods, and needle receptaclesdisclosed herein, a width of the needle driver slot varies along thelength of the needle driver slot.

In many embodiments of the apparatuses, methods, and needle receptaclesdisclosed herein, the needle driver slot includes a first edge and asecond edge that is opposite the first edge, the first edge and thesecond edge being separated by a width, and wherein the width variesalong the length of the needle driver slot.

In many embodiments of the apparatuses, methods, and needle receptaclesdisclosed herein, the needle driver slot includes a first edge and asecond edge that is proximate the first edge, the first edge and thesecond edge being separated by a width, and wherein the width variesalong the length of the needle driver slot.

In many embodiments of the apparatuses, methods, and needle receptaclesdisclosed herein, the needle driver slot has a first end and a secondend along a length of the needle driver slot and a width of the needledriver slot at the first end is greater than a width of the needledriver slot at the second end.

In many embodiments of the apparatuses, methods, and needle receptaclesdisclosed herein, the first end is closed and the second end is open forreceiving a needle driver therethough.

In many embodiments of the apparatuses, methods, and needle receptaclesdisclosed herein, the needle driver slot has a first end and a secondend along a length of the needle driver slot and a width of the needledriver slot at the second end is greater than a width of the needledriver slot at the first end.

In many embodiments of the apparatuses, methods, and needle receptaclesdisclosed herein, the first end of the needle driver slot is closed andthe second end of the needle driver slot is open for receiving a needledriver therethough.

In many embodiments of the apparatuses, methods, and needle receptaclesdisclosed herein, the first end of the needle driver slot is proximatethe secure zone and the second end of the needle driver slot isproximate the transition zone.

In many embodiments of the apparatuses, methods, and needle receptaclesdisclosed herein, the first end of the needle driver slot is a greaterdistance from the entry zone than the second end of the needle driverslot.

In many embodiments, the methods, apparatuses, receptacles, kits, andbarriers disclosed herein may further comprise 2-20 tactile bumps alongthe needle driver slot or the needle slot to facilitate localizationinto a plurality of zones. The tactile bumps may be sized to engage theneedle driver moving along the needle driver slot or the needle movingalong the needle slot. Each of the plurality of tactile bumps may definea boundary between adjacent zones in order to decrease bunching of aplurality needles when placed.

In many embodiments, the methods, apparatuses, receptacles, kits, andbarriers disclosed herein may further comprise 5-8 tactile bumps alongthe needle driver slot or the needle slot to facilitate localizationinto individual zones.

In many embodiments, the methods, apparatuses, receptacles, kits, andbarriers disclosed herein may further comprise 5 tactile bumps tofacilitate localization into individual zones.

In many embodiments, the methods, apparatuses, receptacles, kits, andbarriers disclosed herein may further comprise 3-8 tactile bumps tofacilitate localization into individual zones.

In many embodiments, the methods, apparatuses, receptacles, kits, andbarriers disclosed herein may further comprise 3-6 tactile bumps tofacilitate localization into individual zones.

In many embodiments of the methods, apparatuses, receptacles, kits, andbarriers disclosed herein, the tactile bumps are pairs of tactile bumps.

In many embodiments of the methods, apparatuses, receptacles, kits, andbarriers disclosed herein, the tactile bumps are arranged along a lengthof the needle receptacle.

In many embodiments of the methods, apparatuses, receptacles, kits, andbarriers disclosed herein, the tactile bumps are arranged along a lengthof the needle driver slot or needle driver slit.

In many embodiments of the methods, apparatuses, receptacles, kits, andbarriers disclosed herein, the tactile bumps are arranged along a lengthof the needle slot.

In many embodiments of the methods, apparatuses, receptacles, kits, andbarriers disclosed herein, the tactile bumps are arranged a firstdistance from each other along the length. The first tactile bump orbumps may be a second distance from an entrance to the needle slot, thesecond distance being greater than the first distance.

In many embodiments of the methods, apparatuses, receptacles, kits, andbarriers disclosed herein, the needle receptacle is configured to bemounted on a barrier mounting base and the barrier mounting base isconfigured to be mounted on a barrier. The apparatus, method, or needlereceptacle may further comprise a suture pack mounted to the barriermounting base. The apparatus, method, or needle receptacle may furthercomprise a suture pack mounted to the needle receptacle. The apparatus,method, or needle receptacle may further comprise a suture pack mountedto the needle receptacle and the barrier mounting base.

In many embodiments of the apparatuses, methods, or needle receptaclesdisclosed herein, the suture pack is mounted to a barrier mounting baseand the barrier mounting base is mounted to a barrier.

In many embodiments, the apparatuses, methods, or needle receptaclesdisclosed herein may further comprises a needle receptacle mounted tothe barrier mounting base.

In many embodiments, the apparatuses, methods, or needle receptaclesdisclosed herein may further comprise a needle receptacle mounted to thesuture pack.

In many embodiments, the apparatuses, methods, or needle receptaclesdisclosed herein may further comprise a needle receptacle mounted to thesuture pack and the barrier mounting base.

In many embodiments, adhesion of the needle receptacle to the mountingbase is greater than the adhesion of the mounting base to the barrier.

In many embodiments, adhesion of the mounting base to the barrier issufficiently weak to allow manual removal of the mounting base from thebarrier.

In many embodiments, the adhesion of the needle receptacle to themounting base is sufficiently weak to allow removal of the needlereceptacle from the mounting base.

In many embodiments, adhesion of the suture pack to the mounting base isgreater than the adhesion of the mounting base to the barrier.

In many embodiments, adhesion of the suture pack to the needlereceptacle is greater than the adhesion of the mounting base to thebarrier.

Aspects of the present disclosure may provide a method comprising thesteps of orienting a needle with respect to a needle receptacle with thetip of the needle directed away from a direction of translation of theneedle and moving a needle in the direction of translation to an entryzone of a needle receptacle and into a secure zone of the needlereceptacle.

Aspects of the present disclosure may provide a method of inserting aneedle into a needle receptacle. The method may comprise the steps ofplacing the needle at an entry zone of the needle receptacle coupled toa forearm and moving the needle along the needle receptacle in thedirection of translation to secure the needle within a housing of theneedle receptacle. The needle may be oriented with respect to a needlereceptacle with tips of the needle directed away from a direction oftranslation of the needle into the needle receptacle.

Aspects of the present disclosure may provide a method for securing of asuture needle by a surgeon. The method may comprise the steps oforienting a suture needle with respect to a needle receptacle with tipsof the needle directed away from a direction of translation of theneedle, inserting the suture needle into an opening of a needlereceptacle with a needle driver by moving the needle in the direction oftranslation, securing the suture needle inside the needle receptacle,and releasing the suture needle from the needle driver.

In many embodiments, the body of the needle leads the needle tip in thedirection of translation.

In many embodiments, wherein the needle receptacle inhibits translationof the needle into the needle slot when the needle tip leads the needlebody in the direction of translation.

In many embodiments, a translation force to translate the needle withinthe needle slot is twice a great when translating the needle with thetip leading the body as compared to translating the needle with the bodyleading the tip.

In many embodiments, a translation force to translate the needle withinthe needle slot is greater when translating the needle with the tipleading the body as compared to translating the needle with the bodyleading the tip.

In many embodiments, a translation force to translate the needle withinthe needle slot is greater when translating the needle with the tipleading the body as compared to translating the needle with the bodyleading the tip.

In many embodiments, the direction of translation extends between anentry zone of the needle receptacle and a secure zone of a needlereceptacle.

In many embodiments, the direction of translation along a longitudinalaxis of a needle receptacle.

In many embodiments, the direction of translation is along a length of aneedle driver slot.

In many embodiments, the direction of translation is along a length of aneedle driver slit.

In many embodiments, the direction of translation is along a length of auser's forearm.

In many embodiments, the direction of translation extends between awrist and an elbow of a user's arm.

In many embodiments, the direction of translation is parallel to alength of a needle driver slot or slit.

In many embodiments, the direction of translation starts proximate auser's wrist in a direction towards a user's elbow.

In many embodiments, the direction of translation is towards a securezone.

In many embodiments, the direction of translation is towards a closedend of a needle driver slot or slit.

In many embodiments, the direction of translation is towards a proximalend of a needle driver slot or slit.

In many embodiments, the direction of translation is away from a landingzone.

In many embodiments, the direction of translation is away from a entryzone.

In many embodiments, the direction of translation is away fromtransition zone.

Aspects of the present disclosure provide needle receptacles. Anexemplary needle receptacle may comprise a flexible upper structure, aflexible lower structure, and a needle driver receiving slot. Theflexible upper structure and the flexible lower structure may be coupledto each other to define a needle slot to receive needles. The needledriver receiving slot may be formed through the flexible upper structureextending from the perimeter of the upper flexible sheet material.

Another exemplary needle receptacle may comprise a sheet material, aneedle slot, and a needle driver. The sheet material may extend betweena first end and a second end and may be folded onto itself at a fold toform an upper structure and a lower structure, the upper structure andlower structure having substantially parallel planar surfaces in anarrow profile configuration. The substantially parallel planar surfacescan extend within about ten degrees of each other, and can extend withinabout five degrees of parallel to each other. The needle slot may bedefined between the upper structure and the lower structure. The needledriver receiving slot may be formed though the upper structure andextending from the first end towards the fold.

Another exemplary needle receptacle may comprise a first flexible sheetmaterial forming an upper structure, a second flexible sheet materialforming a lower structure, and a slot formed through the first flexiblesheet material and extending from the perimeter of the first flexiblesheet material. The first flexible sheet material and the secondflexible sheet material may be coupled to each other at their respectiveperimeters.

In many embodiments, the needle receptacle is mounted to a rigidstructure.

In many embodiments, the upper structure and lower structure comprisesufficient strength to resist puncture with a sharp tip of a needle withat least 1 pound force applied to the needle tip. The needle may beselected from the group consisting of a tapered suture needle and acutting suture needle. The force may be selected from the groupconsisting of at least 2 pounds, at least 3 pounds and at least 4pounds.

In many embodiments, the upper structure and lower structure comprisesufficient strength to resist puncture with a sharp tip of a needle withat least 0.3 pound force applied to the tip of the needle. The needlemay comprise a United States Surgical Corporation GS-21 needle.

In many embodiments, the upper structure and lower structure comprisesufficient strength to resist puncture with a sharp tip of a needle withat least 0.3 pound force applied to the tip of the needle. The needlemay comprise a United States Surgical Corporation CV-23 needle.

In many embodiments, the upper structure and lower structure comprisesufficient strength to resist puncture with a sharp tip of a needle withat least 0.3 pound force applied to the tip of the needle. The needlemay comprise a United States Surgical Corporation thin bodiedhalf-circle needle.

In many embodiments, the upper structure and lower structure comprisesufficient strength to resist puncture with a sharp tip of a needle withat least 0.3 pound force applied to the tip of the needle, The needlemay comprise a United States Surgical Corporation medium bodiedhalf-circle needle.

In many embodiments, the upper structure and lower structure comprisesufficient strength to resist puncture with a sharp tip of a needle withat least 0.5 pound force applied to the tip of the needle. The needlemay comprise a United States Surgical Corporation GS-21 needle.

In many embodiments, the upper structure and lower structure comprisesufficient strength to resist puncture with a sharp tip of a needle withat least 0.5 pound force applied to the tip of the needle. The needlemay comprise a United States Surgical Corporation CV-23 needle.

In many embodiments, upper structure and lower structure comprisesufficient strength to resist puncture with a sharp tip of a needle withat least 0.5 pound force applied to the tip of the needle. The needlemay comprise a United States Surgical Corporation thin bodiedhalf-circle needle.

In many embodiments, the upper structure and lower structure comprisesufficient strength to resist puncture with a sharp tip of a needle withat least 1 pound force applied to the tip of the needle. The needle maycomprise a United States Surgical Corporation medium bodied half-circleneedle.

In many embodiments, the upper structure and lower structure comprisesufficient strength to resist puncture with a sharp tip of a needle withat least 1 pound force applied to the tip of the needle. The needle maycomprise a United States Surgical Corporation GS-21 needle.

In many embodiments, the upper structure and lower structure comprisesufficient strength to resist puncture with a sharp tip of a needle withat least 1 pound force applied to the tip of the needle. The needle maycomprise a United States Surgical Corporation CV-23 needle.

In many embodiments, the upper structure and lower structure comprisesufficient strength to resist puncture with a sharp tip of a needle withat least 1 pound force applied to the tip of the needle. The needle maycomprise a United States Surgical Corporation thin bodied half-circleneedle.

In many embodiments, the upper structure and lower structure comprisesufficient strength to resist puncture with a sharp tip of a needle withat least 1 pound force applied to the tip of the needle. The needle maycomprise a United States Surgical Corporation medium bodied half-circleneedle.

In many embodiments, the upper structure and lower structure comprisesufficient strength to resist puncture with a sharp tip of a needle withat least 3 pound force applied to the tip of the needle. The needle maycomprise a United States Surgical Corporation GS-21 needle.

In many embodiments, the upper structure and lower structure comprisesufficient strength to resist puncture with a sharp tip of a needle withat least 3 pound force applied to the tip of the needle. The needle maycomprise a United States Surgical Corporation CV-23 needle.

In many embodiments, the upper structure and lower structure comprisesufficient strength to resist puncture with a sharp tip of a needle withat least 3 pound force applied to the tip of the needle. The needle maycomprise a United States Surgical Corporation thin bodied half-circleneedle.

In many embodiments, the upper structure and lower structure comprisesufficient strength to resist puncture with a sharp tip of a needle withat least 3 pound force applied to the tip of the needle. The needle maycomprise a United States Surgical Corporation medium bodied half-circleneedle.

In many embodiments, the upper structure and lower structure areconfigured to flex together in order to increase a distance of theneedle slot between the upper structure and the lower structure from afirst distance in a narrow profile configuration for placement insidesterile packaging to a second distance in an expanded profileconfiguration outside the sterile packaging with the second distancegreater than the first distance in order to receive the needles.

In some embodiments, the first structure contacts the second structurein the narrow profile configuration.

In some embodiments, the first structure contacts the second structurein the narrow profile configuration.

In some embodiments, the first structure and the second structurecomprise sufficient thickness to hold the needles between the firststructure and the second structure.

In some embodiments, the first structure and the second structurecomprise sufficient thickness to secure the needles in a secure zonebetween the first structure and the second structure.

In some embodiments, the upper structure and lower structure aresubstantially flat in the narrow profile configuration. The upperstructure and lower structure may be curved in the expanded profileconfiguration.

In some embodiments, the needle receptacle comprises a length, a width,and a height, the length being greater than width and the width beinggreater than the height. The thickness in the narrow profileconfiguration may be selected from the group consisting of no more than5 mm, no more than 4 mm, no more than 3 mm, no more than 2 mm, no morethan 1 mm, and no more than 0.5 mm. A difference between the firstdistance and the second distance may be selected from the groupconsisting of no more than 3 mm, no more than 2 mm, no more than 1 mm,and no more than 0.5 mm.

In some embodiments, the upper structure and the lower structure eachcomprise a thickness within a range selected from the group consistingof 0.1 mm to 2.5 mm, 0.2 mm to 2 mm, 0.25 mm to 2 mm and 0.5 mm to 1 mm.

In some embodiments, the receptacle comprises a first side and a secondside opposite the first side. The upper structure may be connected tothe lower structure at a first coupling region along the first side anda second coupling region along the second side. The needle slot mayextend between the first coupling region and the second coupling region.A distance between the first coupling region and the second couplingregion may define a width of the needle slot.

In some embodiments, first surface is connected to the second couplingsurface along a third coupling region defining an end of the needleslot.

In some embodiments, the needle receptacle comprises a first open endand a second open end opposite the second open end with the needle slotextending between the first open end and the second open end. The firststructure and the second structure may comprise sufficient stiffness tosecure the needles in the needle slot between the first region and thesecond region.

In some embodiments, the needle receptacle may further comprise a stripof material along a lower surface of the lower structure to adhere theneedle receptacle to a support. The strip of material may be orientedalong a long axis with a long axis of the needle slot to allow the lowerstructure to flex with the upper structure when the distance increasesfrom the first distance to the second distance.

Aspects of the present disclosure may provide sterile kits. An exemplarysterile kit may comprise a sterile packing comprising a sterile barrier,a plurality of needles, and a needle receptacle. The plurality ofneedles may be contained within a needle package. A tip to tip distanceof each of the plurality of needles may be less than a width of theneedle slot. The plurality of needles and the needle receptacle may besterile and contained within the sterile barrier of the sterile kit.

In many embodiments, the tip to tip distance of each of the plurality ofneedles is within a range selected from the group consisting of 75% to100% of the width of the needle slot, 80% to 99% of the width of theneedle slot, and 85% to 98% of the width of the needle slot and 90 to97% of the width of the needle slot.

In many embodiments, the tip to tip distance of each of the plurality ofneedles is within a percentage of the width of the needle slot in theexpanded configuration, the percentage within range selected from thegroup consisting of 75% to 100% of the second width of the needle slot,80% to 99% of the second width of the needle slot, and 85% to 98% of thesecond width of the needle slot and 90 to 97% of the second width of theneedle slot. The needle slot may comprise a length, a width, and aheight, the length being greater than the width and the width beinggreater than the height.

In many embodiments, the upper structure and the lower structure eachcomprise a needle driver slot to receive a needle driver.

In many embodiments, the upper structure and lower structure areconnected to each other at their respective perimeters.

In many embodiments, the upper structure and lower structure areparallel to each other at their respective perimeters.

In many embodiments, the upper structure and lower structure are adheredto each other at their respective perimeters.

In many embodiments, the upper structure forms an upper portion of asecure zone and a transition zone of the needle receptacle.

In many embodiments, the lower structure forms a lower portion of thesecure zone and the transition zone of the needle receptacle.

In many embodiments, the lower structure forms a landing zone of theneedle receptacle.

In many embodiments, the lower structure that forms the landing zone ofthe needle receptacle extends from the transition zone away from thesecure zone.

In many embodiments, the needle receptacle has a length that extendsbetween a first end and a second end. The entry zone may include thefirst end and the secure zone may include the second end. The transitionzone may be between the first end and the second end.

In many embodiments, the lower structure of the entry zone is a landingzone configured to receive a needle and a needle driver tip.

In many embodiments, the needle driver slot extends from an edge of theupper structure in the transition zone into the secure zone,partitioning the upper structure and the edge into separate first andsecond portions within the transition zone.

In many embodiments, first and second portions of the upper structurewithin the transition zone are deformed towards the lower structure,displacing the upper structure from the lower structure and forming anopening in the needle slot therebetween.

In many embodiments, first and second portions of the upper structurewithin the transition zone are folded towards the lower structure,displacing the upper structure from the lower structure and forming anopening in the needle slot therebetween.

In many embodiments, first and second portions of the upper structurewithin the transition zone are folded away from the lower structure,displacing the upper structure from the lower structure and forming anopening in the needle slot therebetween.

In many embodiments, the first and second sheet material is flexible.

In many embodiments, the first and second sheet material chosen from thegroup consisting of: ABS, polycarbonate, polyethylene, polypropylene,thermoformable plastic, and PETG.

In many embodiments, the kit further comprises at least one needle.

In some embodiments, the needle has a length and the needle slot has awidth, the length of the needle being substantially similar to, but lessthan the width of the needle slot.

In some embodiments, the needle has a length and the needle receptaclehas a width, the length of the needle being substantially similar to,but less than the width of the needle receptacle.

In some embodiments, the length of the needle and the width of theneedle slot are such that the needle deforms the needle slot when theneedle is in the needle slot.

In some embodiments, the length of the needle and the width of theneedle slot are such that the upper structure and the lower structure ofthe needle receptacle apply a compressive force on the needle when theneedle is in the needle slot.

In some embodiments, the length of the needle and the width of theneedle slot are such that the needle deforms the upper structure and thelower structure when the needle is in the needle slot.

In some embodiments, the needle is a curved needle having a tip and atail, and the length is defined as a straight-line distance between thetip and the tail.

In some embodiments, the length of the needle is the defined as astraight-line distance between the two ends of the needle.

In some embodiments, the lower structure includes a flap that isfoldable over the upper structure to close the needle slot.

In some embodiments, the lower structure includes a flap that isfoldable over the upper structure to seal the needle slot.

In some embodiments, the flap includes at least a portion of the lowerstructure extending beyond the transition zone away from the securezone.

In some embodiments, the flap includes at least a portion of the entryzone of the lower structure.

In some embodiments, the kit further comprises an adhesive on the flap.

In some embodiments, the adhesive on the flap adheres to the upperstructure to close the needle slot.

In some embodiments, the adhesive on the flap adheres to the upperstructure to seal the needle slot.

In many embodiments, the apparatuses, methods, needle receptacles, andkits disclosed herein may further comprise a stiff structure configuredto receive the needle receptacle. The stiff structure may include anopen side shaped to receive the needle receptacle. The stiff structuremay include a needle driver slot that aligns with a needle driver slotof the needle receptacle when the needle receptacle is within the stiffstructure. The stiff structure may be in the shape of a hexahedron. Thestiff structure may include an upper structure coupled to a lowerstructure, with the stiff structure configured to receive and hold theneedle receptacle between the upper structure and the lower structure.The stiff structure may include an upper structure coupled to a lowerstructure, with the upper structure and lower structure configured toexert a clamping force on the needle receptacle to hold the needlereceptacle to the stiff structure. The stiff structure may include anupper structure, a lower structure, and a wall structure, with the wallstructure coupling the upper structure and the lower structure together.The stiff structure may comprise a receiver configured to receive theneedle receptacle.

The stiff structure may include a first stiff member having first andsecond ends, a second stiff member extending from the first end of thefirst stiff member, and a third stiff member extending from the secondend of the first stiff and in a same plane as the second stiff member.The stiff structure may be configured to receive a needle receptacle ofany of the preceding claims between the second and third stiff members.

In some embodiments, the distance between the second and third member atan end proximate the first member is less than a distance between thesecond and third member at a distal end such that when the needlereceptacle is received within the stiff structure. The second and thirdmembers may impart a force on the needle receptacle, deforming theneedle receptacle and enlarging an entry to the needle slot of theneedle receptacle.

In some embodiments, a width of the needle receptacle at an entry zoneis greater than a width of the needle receptacle at a secure zone suchthat when the needle receptacle is received within the stiff structure.The second and third members may impart a force on the needlereceptacle, deforming the needle receptacle and enlarging an entry tothe needle slot of the needle receptacle.

Aspects of the present disclosure provide needle receptacles. Anexemplary needle receptacle may comprise a first sheet of stiff materialforming an upper structure, a second sheet of stiff material forming alower structure, and a slot formed through the second stiff sheetmaterial and extending from the perimeter of the second stiff sheetmaterial. The first sheet stiff material and the second stiff sheetmaterial may be coupled to each other at their respective perimeters.

In many embodiments, the upper structure and lower structure areparallel to each other at their respective perimeters.

In many embodiments, the upper structure and lower structure are adheredto each other at their respective perimeters.

In many embodiments, the upper structure and lower structure are coupledto each other via walls that extend from the perimeter of the lowerstructure to the perimeter of the upper structure.

In many embodiments, the lateral opening is configured to receive aneedle therethrough.

In many embodiments, the upper structure forms an upper portion of asecure zone and a transition zone of the needle receptacle.

In many embodiments, the lower structure forms a lower portion of thesecure zone and the transition zone of the needle receptacle.

In many embodiments, the lower structure forms a landing zone of theneedle receptacle.

In many embodiments, the lower structure that forms the landing zone ofthe needle receptacle extends from the transition zone away from thesecure zone.

In many embodiments, the needle receptacle has a length that extendsbetween a first end and a second end. The entry zone may include thefirst end and the secure zone may include the second end. The transitionzone may be between the first end and the second end.

In many embodiments, the lower structure of the entry zone is a landingzone configured to receive a needle and a needle driver tip.

In many embodiments, the needle driver slot extends from an edge of theupper structure in the transition zone into the secure zone,partitioning the upper structure and the edge into separate first andsecond portions within the transition zone.

In many embodiments, first and second portions of the upper structurewithin the transition zone are deformed towards the lower structure,displacing the upper structure from the lower structure and forming anopening in the needle slot therebetween.

In many embodiments, first and second portions of the upper structurewithin the transition zone are folded towards the lower structure,displacing the upper structure from the lower structure and forming anopening in the needle slot therebetween.

In many embodiments, the lower structure includes a flap that isfoldable over the upper structure to close the needle slot.

In many embodiments, the lower structure includes a flap that isfoldable over the upper structure to seal the needle slot.

In many embodiments, the flap includes at least a portion of the lowerstructure extending beyond the transition zone away from the securezone.

In many embodiments, the flap includes at least a portion of the entryzone of the lower structure.

In many embodiments, the needle receptacle further comprises an adhesiveon the flap.

In many embodiments, the adhesive on the flap adheres to the upperstructure to close the needle slot.

In many embodiments, the adhesive on the flap adheres to the upperstructure to seal the needle slot.

In many embodiments, the needle receptacle further comprises one or moreneedle retainers within the needle slot.

In many embodiments, the needle retainers include at least one magnet.

In many embodiments, the at least one magnet is coupled to one or bothof the upper structure and the lower structure.

In many embodiments, the at least one magnet is within one or both ofthe upper structure and the lower structure.

In many embodiments, the needle retainers include at least one adhesivetab.

In many embodiments, the at least one adhesive tab is coupled to one orboth of the upper structure and the lower structure.

In many embodiments, the at least one adhesive tab extends into theneedle slot from one or both of the upper structure and the lowerstructure.

In many embodiments, the at least one adhesive tab includes oppositefirst and second sides, the first side facing an opening in the needleslot and being non-adhesive and the second side facing away from theopening in the needle slot and being adhesive.

In many embodiments, the needle retainer include a compliant materialwithin the needle slot.

In many embodiments, the compliant material includes a first foamstructure that extends from the lower structure towards the upperstructure and applies a retention force to the upper structure through aneedle within the needle slot to retain the needle within the slot.

In many embodiments, the compliant material includes a first foamstructure that extends from the upper structure towards the lowerstructure and applies a retention force to the lower structure through aneedle within the needle slot to retain the needle within the needleslot.

In many embodiments, the compliant material includes a first foamstructure that extends from the upper structure towards the lowerstructure and a second foam structure that extends from the lowerstructure towards the upper structure. A gap may be defined between thefirst foam structure and the second foam structure. The first foamstructure and the second foam structure may exert a force on each otherthrough a needle within the gap to retain the needle within the needleslot.

In many embodiments, the needle retainers include a mechanical dividerthat allows needles to enter the needle slot and resists needles exitingthe needle slot.

In many embodiments, the needle retainers include at least onemechanical divider. The divider may comprise a leading structure, afollowing structure, and a pivot structure. The pivot structure maycouple the leading structure to the following structure. The divider maybe configured to permit needles to move into the needle slot, but resistmovement of needles out of the needle slot.

In many embodiments, the at least one divider separates one needle fromanother needle in an ordered array within the needle slot.

In many embodiments, the leading structure and the following structureextend from the pivot structure at a right angle to each other.

In many embodiments, the leading structure and the following structureextend from the pivot structure at an obtuse angle to each other.

In many embodiments, in an initial configuration, the followingstructure rests against the lower structure of the needle receptacle andthe leading structure extends into the needle slot from the pivotstructure, the pivot structure being coupled to the lower structure ofthe needle receptacle.

In many embodiments, the pivot structure includes a spring that holdsthe following structure against the lower structure of the needlereceptacle.

In many embodiments, the spring is a helical spring.

In many embodiments, in a retention configuration, the followingstructure extends into the needle slot form the pivot structure forminga barrier between a needle within the needle slot and the entry zone ofthe needle receptacle.

In many embodiments, the needle retainers retain the needles in a planararray within the needle slot.

In many embodiments, the needle retainers retain the needles in suchthat they do not overlay with each other within the needle slot.

In many embodiments, the needle retainers retain the needles in an arraywithin the needle slot.

In many embodiments, the needle retainers retain the needles in anunstacked configuration within the needle slot.

In many embodiments, the needle retainers retain the needles within theneedle slot such that each of the needles is separated for each other ofthe needles.

In many embodiments, the retaining features are magnetic.

In many embodiments, the one or more clips extending along the length ofthe needle slot and facing the lateral opening of the needle slot, theone or more clips coupled to the needle receptacle at the lateralopening, such that a needle placed into the needle slot is directed intothe one or more clips, and held securely between the upper and lowerportions of the clips as the needle is translated away from the lateralopening and towards the closed end.

In many embodiments, each clip comprises an upper portion, a lowerportion, and a hinge portion that connects the upper and lower portions,wherein the clip is configured to apply a compressive force against aneedle placed between the upper and lower portions.

In many embodiments of the needle receptacle disclosed herein, the upperstructure and the lower structure are separated by a first distance at afirst end of the secure zone proximate the transition zone and a seconddistance at a second end of the secure zone distal the transition zone,the first distance being less than the second distance such that theupper and lower structures exert a clamping force on a plurality ofneedles arranged between the first and the second end within the needleslot.

In many embodiments of the needle receptacle disclosed herein, theneedle receptacle further comprises a ratcheting cover, engaged with theneedle receptacle and configured to translate longitudinally in a firstdirection towards the entry zone and resist translation away from theentry zone.

In many embodiments of the needle receptacle disclosed herein, theratcheting cover covers the needle driver slot as the cover translatestowards the entry zone.

In many embodiments of the needle receptacle disclosed herein, theneedle receptacle further comprises a needle receiver, the needlereceiver comprising an elongated body having an upper surface and shapedto be received within the secure zone of a needle receptacle, andreceiving tabs extending from the upper surface of the elongated body.

In many embodiments of the needle receptacle disclosed herein, thereceiving tabs are configured to be engaged with a needle.

In many embodiments of the needle receptacle disclosed herein, theneedle engages one or more receiving tabs and translates into the securezone of the needle slot, the needle pulls a portion of the needlereceiver into the needle slot.

In many embodiments of the needle receptacle disclosed herein, theneedle receptacle further comprises an aperture though the lowerstructure and within the entry zone or transition zone, the needlereceiver configured to pass from underneath the lower structure, thoughthe aperture, and into the needle slot.

In many embodiments of the needle receptacle disclosed herein, thereceiving tabs are affixed to the upper surface of the needle receiver.

In many embodiments of the needle receptacle disclosed herein, thereceiving tabs are formed by cutting a slit though the needle receiverand plastically deforming the receiving tab formed by the slit in adirection though the upper surface of the needle receiver.

In many embodiments of the needle receptacle disclosed herein, thereceiving tabs are formed by cutting a slit though the needle receiverand deflecting the receiving tab formed by the slit in a directionthough the upper surface of the needle receiver.

In many embodiments of the needle receptacle disclosed herein, theneedle receiver is configured to ratchet into the needle slot.

In many embodiments of the needle receptacle disclosed herein, theneedle receiver is configured to permit movement of the needle receiverinto the needle driver slot and resist movement of the needle receiverout of the needle slot.

In many embodiments of the needle receptacle disclosed herein, thereceiving tabs are configured to hold the needles within the needle slotin a spaced-apart array.

In many embodiments of the needle receptacle disclosed herein, the arrayis an ordered array.

In many embodiments of the needle receptacle disclosed herein, the arrayis a planar array.

In many embodiments of the needle receptacle disclosed herein, theneedle receptacle further comprises blocking tabs extending from arespective one or both of the upper surface or lower surface towards theother of the upper surface or lower surface and being configured topermit entrance of a needle under load provided by a needle driver butretain the needles within the needle slot when not under load.

In many embodiments of the needle receptacles, apparatuses, barriers,and methods disclosed herein, the stiff portion comprises a rigidportion.

In many embodiments of the needle receptacles, apparatuses, barriers,and methods disclosed herein, the stiff structure comprises a rigidstructure.

In many embodiments of the needle receptacles, apparatuses, barriers,and methods disclosed herein, the stiff material comprises a rigidmaterial.

In many embodiments of the needle receptacles, apparatuses, barriers,and methods disclosed herein, the slot comprises a slit.

Aspects of the present disclosure may provide a method comprisingproviding an apparatus, needle receptacle or barrier as disclosedherein.

Aspects of the present disclosure may provide needle receptacles. Anexemplary needle receptacle may comprise a lower structure and an upperstructure above the lower structure to define a needle slot between theupper structure and the lower structure. The needle slot may comprise aused needle secure zone to secure used needles and a new needle securezone to secure new needles. The needle slot may extend from a first endof the needle receptacle at an entry to the needle slot to a second endof the needle receptacle at the new needle secure zone. The upperstructure may comprise a first edge and a second edge arranged to definea needle driver slot that extends through the upper structure from thenew needle secure zone to the used needle secure zone.

Aspects of the present disclosure provide needle receptacles. Anexemplary needle receptacle may comprise an upper structure, a lowerstructure, and a slot. The upper structure and the lower structure maybe coupled to each other at their respective perimeters. The slot may beformed through the upper structure and may extend from the perimeter ofthe upper structure at a first end to the perimeter of the upperstructure at a second end.

In many embodiments, the first end of the upper structure is at an entryto the used needle secure zone and the second end of the upper structureis at an exit to the new needle secure zone.

In many embodiments, new needles are secured in the new needle securezone and dispensed through the exit to the new needle secure zone.

In many embodiments, used needles are secured in the used needle securezone and received through the entry to the new needle secure zone.

In many embodiments, the needle receptacle may further comprise a stopbetween the new needle secure zone and the used needle secure zone. Thestop may be configured to resist translation of needles between the newneedle secure zone and the used needle secure zone. The stop may extendfrom the lower structure and into the needle driver slot.

In many embodiments, the lower structure of the entry zone is a landingzone configured to receive a tip of a needle driver.

Aspects of the present disclosure may provide a sterile kit. The sterilekit may comprise a sterile packing comprising a sterile barrier, asuture pack, a needle receptacle of as disclosed herein, and a barriermounting base. The suture pack and needle receptacle may be coupled tothe barrier mounting base. The sterile kit may further comprise a sheetstructure. The barrier mounting base may be coupled to the sheetstructure.

Aspects of the present disclosure may provide a sterile kit. The sterilekit may comprise a sterile packing comprising a sterile barrier, asuture pack, a needle receptacle as disclosed herein, a barrier mountingbase, and a sheet structure. The suture pack, needle receptacle, and thebarrier mounting base may be coupled to the sheet structure. The barriermounting base or the sheet structure may include a living hinge.

The needle receptacles disclosed herein may further comprise needleretention features within the needle slot to hold contaminated surgicalneedles therein.

In many embodiments, the needle retention features comprise foamdisposed between upper and lower surfaces within the needle slot.

In many embodiments, the foam comprises urethane foam.

In many embodiments, the needle retention features comprise loop andhook fasteners disposed between upper and lower surfaces within theneedle slot.

In many embodiments, the needle retention features comprise a pluralityof protrusions extending from one or both of upper and lower surfaceswithin the needle slot.

In some embodiments, the plurality of protrusions comprise dimples.

In some embodiments, the plurality of protrusions compriseprotuberances.

In some embodiments, the plurality of protrusions comprise filaments.

In some embodiments, the plurality of protrusions are angled away fromthe at least one opening to permit the needle to pass into the securezone and to resist movement of the needle toward the at least oneopening.

In some embodiments, the needle retention features comprise flapsdisposed between upper and lower surfaces within the needle slot.

In many embodiments, the needle retention features comprise gel disposedbetween upper and lower surfaces within the needle slot.

In many embodiments, the needle retention features comprisehemispherical nubs disposed upper and lower surfaces within the needleslot.

In many embodiments, the needle retention features comprise angledbristles disposed upper and lower surfaces within the needle slot.

In many embodiments of the barrier disclosed herein, the barrier mayincludes a ferrous metal or magnet to magnetically couple to a needlereceptacle.

In many embodiments of the needle receptacles disclosed herein, theneedle receptacle includes a ferrous metal or magnet to magneticallycouple to a barrier.

In many embodiments of the methods disclosed herein, the support ismounted to a drape over the over a patient.

In many embodiments of the methods disclosed herein, the support ismounted within the near surgical field.

In many embodiments of the methods disclosed herein, the support ismounted to a table within the near surgical field.

In many embodiments of the methods disclosed herein, the support ismounted to a stand within the near surgical field.

In many embodiments of the methods disclosed herein, the support ismounted at a location opposite the surgeon from an incision.

In many embodiments of the methods disclosed herein, the support ismounted proximal the incision of the patient.

In many embodiments of the methods disclosed herein, the support ismounted distal the incision of the patient.

In many embodiments of the methods disclosed herein, the support ismounted superior the incision of the patient.

In many embodiments of the methods disclosed herein, the support ismounted inferior the incision of the patient.

In many embodiments of the barrier mounting base disclosed herein, thebarrier mounting base includes a flat surface for coupling one or moreof a needle receptacle and a suture pack either directly or indirectly.

In many embodiments of the barrier mounting base disclosed herein, thebarrier mounting base includes a concave surface shaped to receive abarrier therein.

In many embodiments of the barrier mounting base disclosed herein, theconcave surface is opposite the flat surface.

In many embodiments of the barrier mounting base disclosed herein, thebarrier mounting base further comprises torsional stiffeners extendingfrom a surface of the barrier mounting base and is configured toincrease the torsional rigidity of the barrier mounting base as comparedto the barrier mounting brace without the torsional stiffeners.

In many embodiments of the barrier mounting base disclosed herein, thebarrier mounting base further comprises first and second extensionsalong respective first and second sides of the barrier mounting base andconfigured to couple with a barrier. A lower surface of the barriermounting base may contact a curved surface of the barrier at a firstlocation and the first and second extensions may contact the curvedsurface of the batter at respective second and third locations.

In many embodiments of the support disclosed herein, the supportcomprises a sheet structure including a first hinge separating a base ofthe support from a mounting surface of the support.

In many embodiments of the support disclosed herein, the base isconfigured to couple the support to a surgical drape and the mountingsurface is configured to couple to a needle receptacle.

In many embodiments of the support disclosed herein, the base isconfigured to couple the support to a surgical drape and the mountingsurface is configured to couple to a needle receptacle.

In many embodiments of the support disclosed herein, the mountingsurface is at an angle with the base of between 30 degrees and 90degrees.

In many embodiments of the support disclosed herein, the mountingsurface is at an angle with the base of between 60 degrees and 75degrees.

In many embodiments of the support disclosed herein, the mountingsurface is at an angle with the base of between 45 degrees and 75degrees.

In many embodiments of the support disclosed herein, the mountingsurface is at an angle with the base of between 45 degrees and 90degrees.

In many embodiments of the support disclosed herein, the supportcomprises a sheet structure including a first hinge separating a base ofthe support from a mounting surface of the support.

In many embodiments of the support disclosed herein, the supportcomprises a sheet structure including a second hinge separating themounting surface of the support from a adjustment structure that extendsfrom the hinge and engages with the base.

In many embodiments of the support disclosed herein, the supportcomprises a plurality of stops that extend from a surface of the baseand are engagable by the adjustment structure to adjust an angle of themounting surface.

In many embodiments of the support disclosed herein, the support furthercomprises a third hinge between the adjustment structure and a fourthsection, the fourth section coupleable to the base.

In many embodiments of the support disclosed herein, the hinge is aliving hinge.

In many embodiments of the apparatus disclosed herein, the top andbottom of the spindles may include a coupling the top coupling having afirst shape and the bottom coupling being shaped to receive the topcoupling.

In many embodiments of the apparatus disclosed herein, the top andbottom of the spindles may include a coupling the top coupling having afirst shape and the bottom coupling may be shaped to engage with thefirst shape of the top coupling.

In many embodiments of the apparatus disclosed herein, the top of thespindle may include an extension and the top of the spindle includes arecess shaped to receive the extension.

Aspects of the present disclosure may provide a needle receptaclecomprising a lower structure that has a secure zone, an upper structurethat has an entry zone and a secure zone, a needle slot for receivingone or more suture needles between the lower structure and the upperstructure, a ramp structure that forms a lower entry zone, and an upperneedle driver slot that extends through a portion of the upper structureand a lower needle driver slot that extends through portion of the lowerstructure and the ramp structure. The ramp structure may include asurface that is angled away from the needle slot and the upperstructure. The entry zone of the upper structure may be angled away fromthe needle slot and the ramp structure. The needle receptacle mayfurther comprise a compliant structure within the needle slot. Thecompliant structure may apply a holding force against a needle withinthe needle slot and the secure zone to resist translation of the needleout of the needle slot and the secure zone. The upper structure mayapply a holding force against a needle within the needle slot and thesecure zone to resist translation of the needle out of the needle slotand the secure zone.

Aspects of the present disclosure may provide needle receptacles. Anexemplary needle receptacle may comprise first and second elongatedmembers, a first needle retention slot, and a second needle retentionslot. The first and second elongated members may have a first endcoupled to a wall, the first and second members being parallel to eachother and extending from the wall, the first elongated member having afirst surface that faces the second elongated member and the secondelongated member has a second surface that faces the first elongatedmember. The first needle retention slot may be formed in the firstsurface of the first elongated member and may extend along the length ofthe first elongated member. The second needle retention slot may beformed in the second surface of the second elongated member and mayextend along the length of the second elongated member. The first andsecond needle retention slots may together form a secure needle zone forsecuring used suture needles therein.

The first and second elongated members may apply a compressive force tothe used suture needles.

A needle driver slot may be formed between the first and secondelongated members.

Aspects of the present disclosure may provide needle receptacles. Anexemplary needle receptacle may comprise a housing and a cavity. Thehousing may have an upper portion and a lower portion coupled togetherby a hinge portion. The upper portion, lower portion, and hinge portionmay form a u-shape. The cavity formed between the upper portion and thelower portion may be configured storing a plurality of needles.

In many embodiments of the needle receptacle disclosed herein, the hingeportion is spring-loaded to bias the upper and lower portion of thehousing towards one another, such that the needles can be secured withinthe needle slot by the compressive forces exerted by the upper and lowerportions.

In many embodiments of the needle receptacle disclosed herein, each ofthe upper portion and the lower portion comprises a first arm and asecond arm and forming a needle driver slot therebetween.

In many embodiments of the needle receptacle disclosed herein, the lowerportion further comprises an extension that extends away from hinge.

In many embodiments of the needle receptacle disclosed herein, theextension forms a landing zone for a needle to be secured in thehousing. The needle may be placed in contact with an upper surface ofthe extension with the needle driver tip aligned with the needle driverslot.

In many embodiments of the needle receptacle disclosed herein, theneedle driver slot in the lower portion extends into the extension.

In many embodiments of the needle receptacle disclosed herein, theneedle driver slot in the lower portion extends through the extension.

In many embodiments of the needle receptacle disclosed herein, theneedle driver slot is closed at an end of the first or second portionproximate the hinge and open at an end of the first or second portionaway from the hinge.

In many embodiments of the needle receptacle disclosed herein, theneedle receptacle may further comprise blocking tabs extending from arespective one or both of the upper portion or lower portion towards theother of the upper portion or lower portion and being configured topermit entrance of a needle under load provided by a needle driver butretain the needles within the needle slot when not under load.

In many embodiments of the needle receptacle disclosed herein, theneedle receptacle may further comprise lateral walls disposed over outerlateral edges of housing.

In many embodiments of the needle receptacle disclosed herein, thelateral walls are integrated with the housing.

In many embodiments of the needle receptacle disclosed herein, thelateral walls are be removably coupled to outer lateral edges ofhousing.

Aspects of the present disclosure provide needle receptacles. Anexemplary needle receptacle may comprise a lower structure having achannel formed in an upper surface thereof, an upper structure formedfrom a stiff material and a flexible material, a needle slot formedbetween the upper structure and the lower structure for securing usedsuture needles therein, and a needle driver slot formed by the upperstructure between the stiff material and the flexible material and beingabove the channel of the lower structure.

In many embodiments, the needle receptacle further comprises a compliantmaterial within the needle slot between the stiff material of the upperstructure and the lower structure. The compliant material may comprisefoam.

In many embodiments, the needle driver slot formed in the upperstructure is parallel to the channel formed in the upper surface of thelower structure.

In many embodiments, the needle driver slot includes a first edge and asecond edge opposite the first edge.

In many embodiments, the flexible material includes the first edge ofthe needle driver slot and the stiff material includes the second edgeof the needle driver slot

In many embodiments, the first edge separates from the second edge toreceive the needle driver.

In many embodiments, the first edge and the second edge contact eachother in a non-deformed free standing state without a needle driverextending therebetween.

In many embodiments, the first edge and the second edge are spaced apartfrom each other in a non-deformed state, a gap being defined between thefirst edge and the second edge.

In many embodiments, a portion of the lower structure extends beyond anend of the upper structure, forming a landing zone. The needle may beplaced in contact with an upper surface of the extension with the needledriver tip aligned with the needle driver slot.

In many embodiments, receiving a needle receptacle comprises receivingfive or more dispensed surgical needles from a surgeon, wherein thedispensed surgical needles are stabilized and innocuous within theneedle receptacle when received from the surgeon.

In many embodiments, receiving a needle receptacle comprises receivingfive or more reconciled dispensed surgical needles from a person whoreconciled the surgical needles when the needles were within a nearsurgical field, and wherein the dispensed surgical needles arestabilized and innocuous within the needle receptacle when received. Inmany instances, the needles were within the needle receptacle whenreconciled and reconciled with surgical needles of a needle pack withinthe near surgical field.

INCORPORATION BY REFERENCE

All publications, patents, and patent applications mentioned in thisspecification are herein incorporated by reference to the same extent asif each individual publication, patent, or patent application wasspecifically and individually indicated to be incorporated by reference.

INCORPORATION BY REFERENCE

All patents, applications, and publications referred to and identifiedherein are hereby incorporated by reference in their entirety and shallbe considered fully incorporated by reference even though referred toelsewhere in the application.

BRIEF DESCRIPTION OF THE DRAWINGS

The novel features of the invention are set forth with particularity inthe appended claims. A better understanding of the features andadvantages of the present invention will be obtained by reference to thefollowing detailed description that sets forth illustrative embodiments,in which the principles of the invention are utilized, and theaccompanying drawings of which:

FIGS. 1A and 1B illustrate a surgical field and a near surgical field.

FIGS. 1C-1F illustrate a method of using a suture handling apparatus inaccordance with embodiments.

FIG. 2A illustrates a top view of a suture package with needles.

FIG. 2B illustrates adhesive strips.

FIG. 3 illustrates a top view of a suture package attached to a glovewith adhesive strips.

FIG. 4 illustrates a side view of a suture package attached to a glovewith adhesive strips.

FIG. 5 illustrates a top view of a suture package with adhesive regionsfor holding the perimeter of the suture package to a glove.

FIG. 6 illustrates a side view of a suture package with adhesive regionsfor holding the perimeter of the suture package to the glove.

FIG. 7 illustrates a top view of a suture package with needles.

FIG. 8 illustrates a bottom view of a suture package with an adhesive.

FIG. 9 illustrates a side view of a “C” shaped suture package holder.

FIG. 10 illustrates a top view of a “C” shaped suture package holder.

FIG. 11 illustrates a top view of a “C” shaped suture package holderworn over a glove.

FIG. 12 illustrates a side view of a “C” shaped suture package holderwith a suture package worn over a glove.

FIG. 13 illustrates a top view of a platform holding sutures attachedwith straps to a glove.

FIG. 14 illustrates a side view of a platform holding sutures attachedwith straps to a glove.

FIG. 15 illustrates a top view of a magnetic platform attached to aglove.

FIG. 16 illustrates a side view of a magnetic platform attached to aglove.

FIG. 17 illustrates a top view of a multi-layer suture package.

FIG. 18 illustrates a side view of a multi-layer suture package.

FIG. 19 illustrates a top view of a multi-layer suture package attachedto a glove.

FIG. 20 illustrates a side view of a multi-layer suture package attachedto a glove.

FIG. 21 illustrates a top view of a multi-layer suture package with ahook and loop attachment mechanism.

FIG. 22 illustrates a side view of a multi-layer suture package with ahook attachment mechanism.

FIG. 23 illustrates a side view of a lower hook attachment mechanism.

FIG. 24 illustrates a bottom view of a lower hook attachment mechanism.

FIG. 25 illustrates a top view of a multi-layer suture package attachedto a glove.

FIG. 26 illustrates a side view of a multi-layer suture package attachedto a glove.

FIG. 27 illustrates a top view of a used suture container and a suturepackage attached to a glove.

FIG. 28 illustrates a side view of a used suture container and a suturepackage attached to a glove.

FIG. 29 illustrates a front view of an elastic band.

FIG. 30 illustrates a top view of an elastic band.

FIG. 31 illustrates a top view of a suture package held around a wristportion of a glove with elastic bands.

FIG. 32 illustrates a side view of a suture package held around a wristportion of a glove with elastic bands.

FIG. 33 illustrates a top view of a glove having a pocket for holding asuture package and a hole for accessing the sutures.

FIG. 34 illustrates a side view of a glove having a pocket for holding asuture package and a hole for accessing the sutures.

FIG. 35 illustrates a front view of a flip pack suture package.

FIG. 36 illustrates a side view of a flip pack suture package.

FIG. 37 illustrates a top view of a glove holding a flip pack suturepackage.

FIG. 38 illustrates a top view of a platform that includes: toolholders, suture packages and a used needle holder.

FIGS. 39 and 40 illustrate side views of different embodiments ofplatforms having modular attachments.

FIG. 41 illustrates a side view of a platform with an enlarged handportion.

FIG. 42 illustrates a top view of an embodiment of a used needle holder.

FIG. 43 illustrates a side view of an embodiment of a used needleholder.

FIG. 44 illustrates a top view of an embodiment of a used needle holder.

FIG. 45 illustrates a side view of an embodiment of a used needleholder.

FIG. 46 illustrates a top view of an embodiment of a used needle holder.

FIG. 47 illustrates a side view of an embodiment of a used needleholder.

FIG. 48 illustrates a front view of an embodiment of a multi-layerplatform.

FIG. 49 illustrates an embodiments of a platform holding a plurality ofsuture packs, a used suture needle receptacle and tool holders.

FIGS. 50-52 illustrate side views of different embodiments ofmulti-layer platforms.

FIG. 53 illustrates a side view of an embodiment of a multi-layerplatform having modular attachments.

FIGS. 54-57 illustrate top views of embodiments of tool holders onmulti-layer platforms.

FIGS. 58 and 59 illustrate a top view of an embodiment of a suture packcarrier on a multi-layer platform.

FIGS. 60-63 illustrate top views of an embodiment of a suture packcarrier for holding multiple stacked suture packs.

FIGS. 64-67 illustrate side views of embodiments of suture pack carrierson multi-layer platforms.

FIGS. 68-70 illustrate side views of embodiments of multi-layerapparatus that include a dorsum platform and a volar platform.

FIG. 71 illustrates a top view of an embodiment of a multi-layerapparatus that include a dorsum platform and a volar platform.

FIG. 72 illustrates a top view of an embodiment of a platform thatincludes a suture pack holder and a used needle receptacle.

FIG. 73 illustrates a side view of an embodiment of a platform coupledto an arm having an adjustable joint.

FIG. 74 illustrates a side view of an embodiment of a platform coupledto a flexible arm.

FIGS. 75 and 76 illustrate side views of an embodiment of a platformcoupled to an “A” frame structure.

FIG. 77 illustrates a front view of an embodiment of a needle receptacleand suture packet assembly.

FIGS. 78-79 illustrate side views of an embodiment of a needlereceptacle and suture packet assembly.

FIGS. 80-81 illustrate side views of an embodiment of a needlereceptacle and suture packet assembly on a surgical tool.

FIG. 82 illustrates a back view of an embodiment of a needle receptacleand suture packet assembly on a surgical tool.

FIG. 83 illustrates a side view of an embodiment of a needle receptacleand suture packet assembly on a surgical tool.

FIG. 84 illustrates a front view of an embodiment of a needle receptacleand suture packet assembly on a surgical tool.

FIG. 85 illustrates a front view of an embodiment of a needle receptacleand suture packet assembly on a surgical tool.

FIG. 86 illustrates a side view of an embodiment of a needle receptacleand suture packet assembly on a surgical tool.

FIG. 87 illustrates a back view of an embodiment of a needle receptacleand suture packet assembly on a surgical tool.

FIGS. 88 and 89 illustrate side views of an embodiment of a platformwith an inflection point on an arm.

FIG. 90 illustrates a flow chart of a process for using an arm mountedplatform apparatus that includes a suture pack and a needle sharpscontainer.

FIG. 91 illustrates a flow chart of a process for using a tool mountedplatform apparatus that includes a suture pack and a needle sharpscontainer.

FIG. 92 illustrates a top view of an embodiment of a repository housing.

FIGS. 93-95 illustrate side views of an embodiment of a repositoryhousing.

FIG. 96 illustrates a top view of an embodiment of a repository housing.

FIG. 97 illustrates a side view of an embodiment of a repositoryhousing.

FIG. 98 illustrates a top view of an embodiment of a repository housing.

FIG. 99 illustrates a side view of an embodiment of a repositoryhousing.

FIG. 100 illustrates a top view of an embodiment of a repositoryhousing.

FIG. 101 illustrates a side view of an embodiment of a repositoryhousing.

FIGS. 102 and 103 illustrate side views of embodiments of sharpscontainers with perpendicular orientation needles.

FIG. 104 illustrates a top view of an embodiment of a used needlereceptacle with parallel orientation needles.

FIG. 105 illustrates a side view of an embodiment of suture packsattached to a used needle receptacle.

FIG. 106 illustrates a top view of an embodiment of suture packsattached to a used needle receptacle.

FIG. 107 illustrates a side view of an embodiment of suture packsattached to a multi-layer used needle receptacle.

FIG. 108 illustrates a top view of an embodiment of a sharps container.

FIGS. 109 and 110 illustrate side views of an embodiment of a sharpscontainer.

FIG. 111 illustrates a top view of an embodiment of a sharps container.

FIGS. 112 and 113 illustrate side views of an embodiment of a sharpscontainer.

FIG. 114 illustrates a top view of an embodiment of suture packsattached to a multi-layer used needle receptacle.

FIGS. 115 and 116 illustrate side views of an embodiment of suture packsattached to a multi-layer used needle receptacle.

FIG. 117 illustrates a top view of an embodiment of suture packsattached to a multi-layer used needle receptacle.

FIGS. 118 and 119 illustrate side views of an embodiment of suture packsattached to a multi-layer used needle receptacle.

FIG. 120 illustrates a top view of an embodiment of suture packsattached to a multi-layer used needle receptacle.

FIGS. 121 and 122 illustrate side views of an embodiment of suture packsattached to a multi-layer used needle receptacle.

FIG. 123 illustrates a top view of an embodiment of a sharps container.

FIG. 124 illustrates a front view of an embodiment of a sharpscontainer.

FIG. 125 illustrates a side view of an embodiment of a sharps container.

FIG. 126 illustrates a top view of an embodiment of a sharps container.

FIG. 127 illustrates a front view of an embodiment of a sharpscontainer.

FIG. 128 illustrates a side view of an embodiment of a sharps container.

FIG. 129 illustrates a front view of an embodiment of a sharpscontainer.

FIG. 130 illustrates a side view of an embodiment of a sharps container.

FIG. 131 illustrates a front view of an embodiment of a sharpscontainer.

FIG. 132 illustrates a side view of an embodiment of a sharps container.

FIG. 133 illustrates a front view of an embodiment of a sharpscontainer.

FIG. 134 illustrates a side view of an embodiment of a sharps container.

FIG. 135 illustrates a front view of an embodiment of a sharpscontainer.

FIG. 136 illustrates a side view of an embodiment of a sharps container.

FIG. 137 illustrates a side view of an embodiment of a sharps container.

FIG. 138 illustrates a top view of an embodiment of a sharps container.

FIG. 139 illustrates a side view of an embodiment of a sharps container.

FIG. 140 illustrates a top view of an embodiment of a sharps container.

FIG. 141 illustrates a top view of an embodiment of a suture pack.

FIG. 142 illustrates a front view of an embodiment of a sharps containercoupled to a suture pack.

FIG. 143 illustrates an embodiment of a sharps container coupled to asuture pack.

FIG. 144 illustrates a side view of an embodiment of a sharps containercoupled to a suture pack on a surgical tool.

FIG. 145 illustrates a back view of an embodiment of a sharps containercoupled to a suture pack.

FIG. 146 is a block diagram of an integrated suture packet and needlereceptacle 308, in accordance with embodiments.

FIGS. 147A-149 illustrate embodiments of cartridge type sharpscontainers.

FIG. 150 illustrates a cartridge sharps container mounted on a surgicaltool held by a hand.

FIGS. 151 and 152 illustrate an embodiment of a sharps container thatincludes needle locking mechanisms and needle insertion lights.

FIGS. 153 and 154 illustrate an embodiment of a sharps container thatincludes a locking mechanism.

FIGS. 155 and 156 illustrate an embodiment of a sharps container thatincludes needle locking mechanisms and needle insertion indicators.

FIGS. 157-159 illustrate embodiments of connection mechanisms forcoupling surgical tools to cartridge type sharps containers.

FIGS. 160-166 illustrate embodiments of needle receptacles that includefoam covering holes in a receptacle housing.

FIG. 167 illustrates a top view of an embodiment of a needle trapassembly having a suture pack holder coupled via a hinge.

FIG. 168 illustrates a top view of an embodiment of a needle trapassembly having suture pack holders.

FIG. 169 illustrates an exploded top perspective view of an embodimentof a needle trap assembly having a suture pack holder.

FIG. 170 illustrates an exploded side view of an embodiment of a needletrap assembly having a suture pack holder.

FIG. 171 illustrates an exploded bottom perspective view of anembodiment of a needle trap assembly having a suture pack holder.

FIG. 172A illustrates a top perspective view of an embodiment of aneedle trap.

FIGS. 172B-172D show top, side and end views, respectively, of theneedle trap of FIG. 172A.

FIG. 173 illustrates a top perspective view of an embodiment of an upperstructure component of a needle trap.

FIG. 174 illustrates a bottom perspective view of an embodiment of anupper structure component of a needle trap.

FIGS. 175 and 176 illustrate top perspective views of an embodiment of alower structure component of a needle trap.

FIG. 177 illustrates a front view of an embodiment of a needle trap.

FIG. 178 illustrates a cross section side view of an embodiment of aneedle trap.

FIG. 179 illustrates a cross section top view of an embodiment of aneedle slot.

FIGS. 180 and 181 illustrates a block diagram an embodiment of anelectrical needle detection system.

FIGS. 182-184 illustrate an embodiment of a mechanical needle countingsystem.

FIG. 185 illustrates an embodiment of a dye based needle countingsystem.

FIG. 186 illustrates an embodiment a scanner based needle countingsystem.

FIG. 187 illustrates an embodiment a camera based needle countingsystem.

FIG. 188 illustrates an embodiment a pressure based needle countingsystem.

FIG. 189 illustrates an embodiment of a needle counting system withremote monitoring.

FIG. 190 illustrates an embodiment of a needle retainer.

FIG. 191 illustrates an embodiment of a covered needle retainer.

FIG. 192 illustrates an embodiment of a covered needle retainer.

FIGS. 193-194 illustrate an embodiment of a covered needle retainer.

FIG. 195 illustrates an embodiment of a magnetic needle retainer.

FIGS. 196-197 illustrate an embodiment of a magnetic and foam needleretainer.

FIG. 198 illustrates an embodiment of a magnetic and foam needleretainer.

FIG. 199 illustrates an embodiment of a magnetic needle retainer with acover and suture pack clip.

FIGS. 200-201 illustrate an embodiment of an insert and rotate needleretainer.

FIG. 202 illustrates an embodiment of an insert and rotate needleretainer.

FIGS. 203-204 illustrate an embodiment of a needle trap.

FIG. 205 illustrates an embodiment of a needle retainer.

FIGS. 206-209 illustrate embodiments of needle retaining systems.

FIGS. 210-214 illustrate an embodiment of a modular needle retainingsystem.

FIGS. 215-217 illustrate an embodiment of a modular needle retainingsystem.

FIGS. 218-219 illustrate embodiments of dome type needle retainers.

FIG. 220 illustrates an embodiment of a needle retainer system.

FIGS. 221-222 illustrate an embodiment of a needle retainer system.

FIGS. 223-225 illustrate an embodiment of an insert and rotate needleretainer.

FIGS. 226-228 illustrate an embodiment of an insert and rotate needleretainer.

FIGS. 229-230 illustrate an embodiment of an insert and rotate needleretainer.

FIGS. 231-232 illustrate an embodiment of an insert and rotate needleretainer.

FIGS. 233-234 illustrate an embodiment of an insert and rotate needleretainer mounted on a forearm barrier.

FIG. 235 illustrates a top view of an embodiment of a barrier.

FIG. 236 illustrates a top perspective view of an embodiment of abarrier placed on a forearm.

FIG. 237 illustrates a bottom view of an embodiment of a barrier.

FIG. 238 illustrates a side view of an embodiment of a barrier.

FIGS. 239-241 illustrates top perspective views of an embodiment of abarrier with a needle trap and suture packs mounted on the barrier.

FIGS. 242-244 illustrate top perspective view of an embodiment of abarrier with needle retainers, suture pack clips and a tool holder.

FIGS. 245-248 illustrate perspective views of an embodiment of a needleretaining and suture pack clip assembly coupled to a tool mountinginterface.

FIG. 249 illustrates a top view of an embodiment of a barrier.

FIGS. 250-252 illustrates an embodiment of method for securing a barrierto a forearm.

FIG. 253 illustrates a top view of an embodiment of a needle trap andsuture pack carriers mounted on a barrier.

FIG. 254 illustrates a bottom view of an embodiment of a barrier.

FIGS. 255-256 illustrate an embodiment of a barrier placed on a forearm.

FIG. 257 illustrates a perspective view of an embodiment of a needletrap assembly having a tool mounting interface coupled to a surgicaltool.

FIG. 258 illustrates a front view of an embodiment of a needle trapassembly having a tool mounting interface coupled to a surgical tool.

FIG. 259 illustrates a side view of an embodiment of a needle trapassembly having a tool mounting interface coupled to a surgical tool.

FIG. 260 an exploded perspective view of an embodiment of a needle trapassembly having a tool mounting interface.

FIG. 261 illustrates a front view of an embodiment of surgical gownhaving barriers attached to the sleeves.

FIG. 262 illustrates a side view of an embodiment of a sleeve having abarrier.

FIGS. 263-265 illustrate cross section views of barriers coupled tosurgical gown fabrics.

FIGS. 266-267 illustrate an embodiment of a blade ring.

FIG. 268 illustrates an embodiment of a blade ring.

FIGS. 269-271 illustrate an embodiment of a surgical tool cap suturecutter.

FIGS. 272-273 illustrate an embodiment of a surgical tool having anintegrated suture cutter.

FIG. 274 illustrates an embodiment of a surgical tool mounted scissors.

FIGS. 275-278 illustrate an embodiment of a retractable cable mountedscissors.

FIG. 279-280 illustrate an embodiment of a barrier mounted suturecutter.

FIG. 281 illustrates an embodiment of a scissors within a safety guard.

FIGS. 282-285 illustrate an embodiment of a suture cutter.

FIGS. 286-289 illustrate different embodiments of surgical gloves.

FIG. 290 illustrates a cross sectional side view of an embodiment of aneedle trap.

FIG. 291 illustrates a front view of an embodiment of a needle trap.

FIG. 292 illustrates a cross sectional side view of an embodiment of aneedle trap.

FIG. 293 illustrates a front view of an embodiment of a needle trap.

FIGS. 294-297 illustrate cross sectional side views of embodiments ofneedle traps.

FIG. 298 illustrates a front view of an embodiment of a needle trap.

FIG. 299 illustrates a cross sectional side view of an embodiment of aneedle trap.

FIG. 300 illustrates a front view of an embodiment of a needle trap.

FIGS. 301-302 illustrate cross sectional side views of an embodiment ofa needle trap.

FIG. 303 illustrates a cross sectional side view of an embodiment of aneedle trap.

FIG. 304 illustrates a front view of an embodiment of a needle trap.

FIGS. 305-306 illustrate cross sectional side views of an embodiment ofa needle trap.

FIG. 307 illustrates an exemplary embodiment of an integrated sutureneedle dispensing and securing apparatus.

FIG. 308 is a block diagram of a sterile suturing kit in accordance withembodiments.

FIG. 309 shows a suture pack and needle receptacle coupled to a barriermounting base.

FIG. 310 shows the needle receptacle as in FIG. 309. FIG. 310 shows atop oblique view of the needle receptacle in a fully assembledconfiguration.

FIG. 311 shows a top exploded view of the needle receptacle with needlescoupled to the barrier mounting base.

FIG. 312 shows a bottom exploded view of the needle receptacle withneedles coupled to the barrier mounting base as in FIGS. 310 and 311.

FIG. 313 shows a top oblique view of the top shell of the needlereceptacle as in FIG. 312.

FIG. 314 shows a bottom oblique view of the top shell as in FIG. 313.

FIG. 315 shows a close-up bottom oblique view of the top shell as inFIG. 314.

FIG. 316 shows a top oblique view of the bottom shell of the needlereceptacle as in FIG. 310.

FIG. 317 shows a bottom oblique view of the bottom shell as in FIG. 316.The lower needle driver slot is shown extending along a long axis of theneedle receptacle.

FIG. 318 shows a top oblique view of the bottom shell as in FIG. 317with compressive members placed thereon.

FIG. 319 shows a longitudinal cross-sectional view of the top and bottomshell as in FIG. 310 without the compressive members.

FIG. 320 shows the fully assembled needle receptacle with the needle ina transverse cross-sectional view for the needle receptacle as shown inFIG. 310.

FIG. 321 shows advancement of the needle positioned into the needlereceptacle as in FIG. 310.

FIGS. 322A and 322B show a needle stabilized in the needle receptacle.

FIG. 323 shows dimensions of the needle receptacle as in FIG. 310. Theneedle receptacle comprises a cross-sectional dimension of the needledriver slot that is shown with dimension.

FIGS. 324A and 324B show a needle containment groove defined with ahousing similar to FIG. 310.

FIGS. 325A-325C show needles placed in a needle receptacle as in FIG.324A.

FIGS. 326A-326D show needles placed in a needle receptacle as describedherein, for example, with reference to FIGS. 310 and 324.

FIG. 327A shows ratcheting along the groove of the needle driver slotfor example with reference to FIGS. 310 and 324.

FIG. 327B shows varied apertures along the needle driver slot.

FIG. 328 shows a chiral barrier for placement on the left forearm of thesurgeon.

FIG. 329 shows a top plan view of the barrier of FIG. 328 prior tothermal forming.

FIG. 330 shows axes of the pre-formed barrier.

FIG. 331 shows a view from the proximal end of the barrier toward thedistal end of the barrier.

FIG. 332 schematically illustrates structures of chiral barrier.

FIG. 333 shows outer surface profiles of the barrier and the curved pathof the center of the barrier.

FIGS. 334A-334C illustrate the use of a needle handling system asdescribed herein.

FIG. 335 illustrates an exemplary embodiment of a needle receptaclecomprising a cover for the needle driver slot.

FIG. 336 illustrates another exemplary embodiment of a needle receptaclecomprising a cover for the needle driver slot.

FIGS. 337A-337D illustrate another exemplary embodiment of a needlereceptacle comprising a cover for the needle driver slot.

FIG. 338 illustrates an exemplary embodiment of a needle receptaclecomprising a compressive cover for the needle driver slot.

FIG. 339 illustrates another exemplary embodiment of a needle receptaclecomprising a compressive cover for the needle driver slot.

FIGS. 340A-340C illustrate another exemplary embodiment of a needlereceptacle comprising a compressive cover for the needle driver slot.

FIGS. 341A-341C illustrate exemplary embodiments of a backlit needlereceptacle.

FIGS. 342A-342F schematically illustrate various configurations of aneedle driver slot of a needle receptacle.

FIGS. 343A-343G illustrate exemplary embodiments of a swaged needledevice for dispensing and securing a swaged needle.

FIGS. 344A-344C illustrate an exemplary embodiment of a tool-mountedneedle receptacle.

FIGS. 345A-345D illustrate another exemplary embodiment of atool-mounted needle receptacle.

FIG. 346 illustrates an exemplary embodiment of a device for securing aplurality of needles, in accordance with many embodiments.

FIGS. 347A-347D illustrate an exemplary embodiment of a device forsecuring a plurality of needles, in accordance with many embodiments.

FIGS. 348A-348B illustrate an exemplary embodiment of a device forsecuring a plurality of needles, in accordance with many embodiments.

FIGS. 349A-349B illustrate an exemplary embodiment of a device forsecuring a plurality of needles, in accordance with many embodiments.

FIGS. 350A-350B illustrate an exemplary embodiment of a device forsecuring a plurality of needles, in accordance with many embodiments.

FIGS. 351A-351C illustrate an exemplary embodiment of a device forsecuring a plurality of needles, in accordance with many embodiments.

FIGS. 352A-352C illustrate an exemplary embodiment of a device forsecuring a plurality of needles, in accordance with many embodiments.

FIG. 353 illustrates an exemplary embodiment of a clip assembly forsecuring a needle, in accordance with many embodiments.

FIGS. 354A-354G illustrate an exemplary embodiment of a device forsecuring a plurality of needles, in accordance with many embodiments.

FIGS. 355A-355B illustrate an exemplary embodiment of a device forsecuring a plurality of needles, in accordance with many embodiments.

FIG. 356 illustrates an exemplary embodiment of a device for securing aplurality of needles, in accordance with many embodiments.

FIGS. 357A-357C illustrate an exemplary embodiment of a device forsecuring a plurality of needles, in accordance with many embodiments.

FIG. 358 illustrates an exemplary embodiment of a device for securing aplurality of needles, in accordance with many embodiments.

FIG. 359 illustrates an exemplary embodiment of a device for securing aneedle, in accordance with many embodiments.

FIGS. 360A-360C illustrate an exemplary embodiment of a device forsecuring a plurality of needles, in accordance with many embodiments.

FIG. 361A illustrates an exemplary embodiment of a device for securing aplurality of needles, in accordance with many embodiments.

FIG. 361B illustrates an exemplary embodiment of a device for securing aplurality of needles, in accordance with many embodiments.

FIGS. 362A-362D illustrate an embodiment of a needle receptacle with arotatable cover.

FIG. 363 illustrates another embodiment of a needle receptacle with arotatable cover.

FIG. 364 illustrates another embodiment of a needle receptacle with arotatable cover.

FIGS. 365A-365D illustrate an exemplary embodiment of a swaged needledevice for dispensing and securing a swaged needle, comprising arotatable cover.

FIGS. 366A-366C illustrate an exemplary embodiment of an integratedsuture needle dispensing and securing apparatus.

FIG. 367 illustrates an exemplary embodiment of a suture needledispensing device.

FIGS. 368A-368B illustrate an exemplary configuration for coupling aneedle receptacle to a suture package.

FIGS. 369A-369C illustrate another exemplary configuration for couplinga needle receptacle to a needle dispensing unit.

FIG. 370A schematically illustrates an exemplary configuration of aneedle dispensing unit and a needle receptacle mounted on a barrier.

FIG. 370B schematically illustrates another exemplary configuration of aneedle dispensing unit and a needle receptacle mounted on a barrier.

FIGS. 371A-371B illustrate an exemplary configuration of a needlereceptacle mounted on a barrier.

FIGS. 372A-372B illustrate exemplary labels that may be provided forcommercially available suture packages to be used with a needle handingsystem described herein.

FIGS. 373A-373B illustrate an exemplary embodiment of a forearm barriercomprising sliding longitudinal panels.

FIGS. 374A-374B illustrate an exemplary embodiment of a forearm barriercomprising sliding c-shaped sections or “bracelets”.

FIG. 375 illustrates a barrier comprising one or more plug-ins forelectrically powered surgical tools.

FIGS. 376A-376D illustrate a barrier comprising one or more tool loopsfor supporting one or more surgical tools.

FIGS. 377A-377B illustrate exemplary embodiments of surgical gownscomprising integrated forearm barriers.

FIGS. 378A-378B illustrate exemplary staging devices suitable forincorporation with the needle handling systems as described herein.

FIGS. 379A-379C illustrate exemplary kits for suture handling systems.

FIGS. 380A-380B illustrate exemplary needle receptacles suitable forincorporation with the needle handling systems as described herein.

FIGS. 381A-381B illustrate exemplary needle receptacles suitable forincorporation with the needle handling systems as described herein.

FIGS. 382A-382D illustrate optional configurations of a needlereceptacle as in FIGS. 380A-381B.

FIGS. 383A-383C show an exemplary needle receptacle configured to storea plurality of needles in an ordered array.

FIGS. 384A-384B show another exemplary needle receptacle configured tostore a plurality of needles in an ordered array.

FIGS. 385A-385B illustrate an exemplary embodiment of devices forsecuring a plurality of needles, in accordance with many embodiments.

FIGS. 386A-386B illustrate an exemplary embodiment of devices forsecuring a plurality of needles, in accordance with many embodiments.

FIGS. 387A-387D illustrate longitudinal cross-sectional views ofexemplary internal spring dividers suitable for incorporation with theneedle handling systems as described herein.

FIG. 388 illustrates a longitudinal cross-sectional view of an exemplaryembodiment of a device for securing a plurality of needles, suitable forincorporation with the needle handling systems as described herein.

FIGS. 389A-389B illustrate an exemplary embodiment of a device forsecuring a plurality of needles comprising internal filaments, inaccordance with many embodiments.

FIGS. 390A-390E illustrate exemplary embodiments of needle driver slotcovers suitable for incorporation with the needle handling systems asdescribed herein.

FIGS. 391A-391B illustrate exemplary embodiments of devices for securinga plurality of needles with a ratcheting cover, in accordance with manyembodiments.

FIGS. 392A-392F illustrate exemplary embodiments of devices for securinga plurality of needles, in accordance with many embodiments.

FIGS. 392A1-392A12 illustrate exemplary embodiments of devices forsecuring a plurality of needles, in accordance with many embodiments.

FIGS. 392B1-392B5 illustrate exemplary embodiments of devices forsecuring a plurality of needles, in accordance with many embodiments.

FIGS. 393A-393B illustrate an exemplary embodiment of a device forsecuring a plurality of needles, in accordance with many embodiments.

FIG. 394 illustrates an exemplary embodiment of a device for securing aplurality of needles, in accordance with many embodiments.

FIG. 395 illustrates an exemplary embodiment of a device for securing aplurality of needles, in accordance with many embodiments.

FIG. 396 illustrates an exemplary embodiment of a device for securing aplurality of needles, in accordance with many embodiments.

FIGS. 397A-397B illustrate exemplary embodiments of a device fordispensing and securing a plurality of needles, in accordance with manyembodiments.

FIGS. 398A-398D illustrate exemplary embodiments of a barrier mountingbase with a needle dispenser and needle trap mounted to a barrier fordispensing and securing a plurality of needles, in accordance with manyembodiments.

FIGS. 399A-399D illustrate exemplary embodiments of a device fordispensing one or more swaged needles, in accordance with manyembodiments.

FIGS. 400A-400D illustrate exemplary embodiments of a device fordispensing one or more swaged needles, in accordance with manyembodiments.

FIGS. 401A-401C illustrate exemplary embodiments of a base for mountingone or more devices for dispensing and/or securing a plurality ofneedles, in accordance with many embodiments.

FIGS. 402A-402C illustrate exemplary embodiments of a base for mountingone or more devices for dispensing and/or securing a plurality ofneedles, in accordance with many embodiments.

FIGS. 403A-403C illustrate exemplary embodiments of a base for mountingone or more devices for dispensing and/or securing a plurality ofneedles, in accordance with many embodiments.

FIGS. 404A-404C illustrate exemplary embodiments of a base for mountingone or more devices for dispensing and/or securing a plurality ofneedles, in accordance with many embodiments.

FIGS. 405A-405B illustrate exemplary mounting positions of a base formounting one or more devices for dispensing and/or securing a pluralityof needles, in accordance with many embodiments.

FIGS. 406A-406C illustrate exemplary kits including one or more devicesfor dispensing and/or securing a plurality of needles, in accordancewith many embodiments.

FIGS. 407-413 illustrate an exemplary embodiment of needle receptacle,in accordance with many embodiments.

FIGS. 414-418 illustrate an exemplary embodiment of needle receptacle,in accordance with many embodiments.

DETAILED DESCRIPTION

The present invention is directed towards systems and methods forimproving the efficiency of operating rooms. The embodiments disclosedherein are well suited for combination with many prior systems andmethods, such as prior suture packs, prior needle holders, and prioroperating rooms and personnel.

Although specific reference is made to the placement of used needles ina used needle container, the embodiments disclosed herein are wellsuited for use with needles dispensed from a suture pack and placed in aused needle container without suturing the patient, for example.

Definitions

Secure—The needle is secure means that the tip of the needle isprevented from compromising sterility or coming into contact with skinof the patient or surgical staff. When used with the sharps container,the used needle is physically secured from falling out of container.Sharps can include needles and tools or other objects which have one ormore sharp surfaces that can puncture the skin of the patient orsurgical staff.

In many embodiments, a secure needle as described herein is secured toprevent both the leading and trailing ends or tips of the needle fromcoming into contact with skin, gloves, surgical apparel of the surgicalstaff, surgical drape, or patient.

As used herein like characters such as letters and numerals refer tolike elements.

As disclosed herein, a used suture needle encompasses a suture needledispensed from a suture pack.

As used herein the terms “needle driver” and “needle holder” are usedinterchangeably.

As used herein the terms “armed sutures” and “armed needles” are usedinterchangeably.

As used herein the terms “used needle holder”, “needle receptacle”,“used needle receptacle, “used suture needle receptacle”, “sharpscontainer”, “needle trap”, and “needle receptacle means” are usedinterchangeably.

As used herein the terms “suture package”, “suture pack” and “suturepackage means” are used interchangeably.

As used herein the terms “barrier” and “barrier means” are usedinterchangeably.

As used herein the terms “support” and “support means” are usedinterchangeably.

As used herein the terms “platform” and “platform means” are usedinterchangeably.

As used herein “secure” means fixed or fastened so as not to give way,become loose, or be lost.

As used herein “innocuous” means incapable of contact with a humanfinger.

One approach for improving operating room efficiency is to reduce thedependence of the surgeon on the surgical assistant. For example, asurgical procedure can include performing a surgical procedure and thenclosing a patient's surgical incisions after the procedure is completed.The closing generally includes installing surgical sutures to hold thepatient's body tissue together after the surgery. This surgical sutureprocedure can include needles loaded with sutures that are stored in aneedle package and a needle driver. When needed, the surgeon uses aneedle driver to grasp and remove a needle from the suture package. Theneedle point is pressed into the flesh, advanced along the trajectory ofthe needle's curve until it emerges, and pulled through. The trailingthread is then tied into a knot, usually a square knot or surgeon'sknot. Ideally, sutures bring together the wound edges, without causingindenting or blanching of the skin, since the blood supply may beimpeded and thus increase infection and scarring. Placement varies basedon the location, but the distance between each suture generally is equalto the distance from the suture to the wound edge. The most commonstitch is a simple interrupted stitch with the suture thread cut betweeneach individual stitch. Because each stitch may require a separateneedle and the patient may require many stitches, the surgeon may needto handle many different needles. The size and shape of the needles mayalso vary depending upon the patient's needs.

An embodiment, the present invention is directed towards a system forimproving efficiency by eliminating the need for the assistant toprovide needles to the surgeon when closing a patent's surgical wounds.Eyed or reusable needles are needles with holes or eyes, which aresupplied separate from their suture thread. The suture must be threadedon site, as is done when sewing at home. The advantage of this is thatany thread and needle combination is possible to suit the job at hand.Swaged, or atraumatic, needles with sutures comprise a pre-packedeyeless needle attached to a specific length of suture thread. Thesuture manufacturer swages the suture thread to the eyeless atraumaticneedle at the factory. The chief advantage of this is that the doctor orthe nurse does not have to spend time threading the suture on theneedle, which may be difficult for very fine needles and sutures. Alsothe suture end of a swaged needle is narrower than the needle body,eliminating drag from the thread attachment site. In eyed needles, thethread protrudes from the needle body on both sides, and at best causesdrag. When passing through friable tissues, the eye needle and suturecombination may thus traumatize tissues more than a swaged needle, hencethe designation of the latter as “atraumatic”.

There are several shapes and sizes of surgical needles. These include:Straight, ¼ circle, ⅜ circle, ½ circle, ⅝ circle, compound curve, halfcurved (also known as ski), half curved at both ends of a straightsegment (also known as canoe), etc. Subtypes of the ½ circle needleshape include, from larger to smaller size, CT, CT-1, CT-2 and CT-3. Theski and canoe needle design allows curved needles to be straight enoughto be used in laparoscopic surgery, where instruments are inserted intothe abdominal cavity through narrow cannulas. Needles may also beclassified by their point geometry, examples include: taper (needle bodyis round and tapers smoothly to a point), cutting (needle body istriangular and has a sharpened cutting edge on the inside curve),reverse cutting (cutting edge on the outside), trocar point or tapercut(needle body is round and tapered, but ends in a small triangularcutting point), blunt points for sewing friable tissues, side cutting orspatula points (flat on top and bottom with a cutting edge along thefront to one side) for eye surgery, etc. Atraumatic needles may bepermanently swaged to the suture or may be designed to come off thesuture with a sharp straight tug. These “pop-offs” are commonly used forinterrupted sutures, where each suture is only passed once and thentied.

In an embodiment, operating room efficiency can be improved by allowingthe surgeon to load suture needles to a needle driver. A surgeon may usea dominant hand to hold the needle driver and one or more suture packetscan be attached to the non-dominant limb of the surgeon. The surgeon canthen grasp the new suture needles from the suture packet on thenon-dominant limb.

For example, if the user is right handed, the surgeon may attach thesuture package to the left arm or hand and use the right hand to handlea needle driver. The user can grasp a portion of a needle with theneedle driver and remove the needle from the suture package. The usercan then use the needle driver to press the needle point into the fleshof the patient. The needle is advanced along the trajectory of theneedle's curve until it emerges from the flesh, and the needle andsuture are pulled through. The trailing thread is then tied into a knot,usually a square knot or surgeon's knot.

It has been estimated that there are over one billion passages ofneedles per year in the US. This high needle use results in a seriousrisk of injury. The inventive system reduces this risk because theneedles are only handled by the surgeon. Because there is a reducednumber of passes of sharp needles between surgical personnel there arefewer chances of having accidentally dropped needles, drape penetrationor retained foreign objects within the patient.

FIGS. 1A and 1B illustrate a surgical field and a near surgical field.FIG. 1A illustrates a perspective view and FIG. 1B illustrates a topview of a surgeon performing an operation within the near surgicalfield, using methods and apparatuses in accordance with embodiments. Thesurgeon of FIG. 1A is shown holding a needle driver with his dominantright hand, while holding a tissue forceps with his non-dominant lefthand. A suture handling apparatus in accordance with embodiments isshown mounted on the surgeon's non-dominant left forearm. The surgeon ofFIG. 1B is shown holding a needle driver with his dominant left hand,while holding a tissue forceps with his non-dominant right hand. Asuture handling apparatus in accordance with embodiments is shownmounted on the surgeon's non-dominant right forearm. As shown in FIGS.1A and 1B, the suture handling apparatus as described herein can besupported on a surgeon's non-dominant limb so that the surgeon mayperform maneuvers for an operation using his dominant hand, regardlessof whether the surgeon is right-handed or left-handed. Thisconfiguration can allow the surgeon or other user to move the needleless than two feet from the suture pack to the wound (such as a surgicalincision) and less than two feet from the wound to the needlereceptacle. This decreased range of travel of the suture from dispensingto suturing to secure provides improved safety.

A “surgical field” can include a space within an operating room wherethe patient and surgeon are located during surgery. A “near surgicalfield” 313 can be a much smaller space that is in close proximity to theincision 317 on the patient 315 and the surgeon. The near surgical field313 may comprise a space disposed between the surgeon 319 and theincision 317. For example, the near surgical field can comprise a length316 extending between a surgeon and an incision of a patient and a width318 extending transverse to the length, the width comprising no morethan about 24 inches (61 cm) across. The entire near surgical field canalso be within the field of view 311 of the surgeon 319.

The near surgical field may be conceptualized as the space bound by theneutral planes 320 of the surgeon's arms, such that no external rotationof the arms or the shoulders beyond a position of neutrality isnecessary for the surgeon to reach an object positioned within the nearsurgical field. For example, the near surgical field can comprise aspace wherein the surgeon's arms retain some degree of bending and canrotate internally from the neutral planes 320 (in the direction shown byarrows 322 in FIG. 2B). Frequently, a surgeon's arms may be in a neutralposition, for example with the arms positioned at the sides and theelbows bent at about 90 degrees. From this neutral position, the nearsurgical field 313 can comprise the space between the edges of theelbows to the tips of the fingers, and about 6 inches beyond the tips ofthe fingers. Generally, the surgeon does not have to engage gross motorcontrol in order to reach an object positioned within the near surgicalfield. On the other hand, to reach for an object positioned outside thenear surgical field, a surgeon would generally be required to engagegross motor control. Since a surgeon usually engages only fine motorcontrol during the performance of a surgical operation, it is desirablethat the surgeon not be required to reach for an object positionedoutside of the near surgical field during the operation, in order toprevent interruptions to the surgeon's workflow. The practice of passingindividual suture needles between a surgeon and an assistant oftenrequires the surgeon to reach outside of the near surgical field,therefore breaking the surgeon's workflow, in addition to exposing boththe surgeon and the assistant to risks of needle-stick injury during thepassing of the needles.

As shown in FIGS. 1A and 1B, the embodiments described herein can allowa surgeon 319 to work within the near surgical field 313 without havingto pass individual suture needles in and out of the near surgical field.The surgeon can be provided with a support comprising platform 145 asdescribed herein, shown mounted on the volar forearm of the surgeon 319in FIGS. 1A and 2B. Platform 145 can support a suture pack 101 and adispensed needle receptacle 157, for example. In many embodiments, whenthe platform 145 is used by the surgeon 319 to install sutures, theplatform 145, incision 317 and the surgical tools 201 will all be withinthe near surgical field 313 and the field of view 313 of the surgeon319, for example. In many embodiments, the near surgical field 313 iswithin about 2 feet of the incision 317. Alternatively or incombination, the near surgical field 313 can be within about 1.5 feet ofthe incision 317. The near surgical field 313 can be within 1 foot ofthe incision 317, for example. According to present embodiments, thesurgeon can perform procedures requiring the use of suture needles bydispensing suture needles from the suture pack 101 mounted within thenear surgical field 313 (e.g., on surgeon's forearm), and securingdispensed needles in a needle receptacle 157 also mounted within thenear surgical field.

In many embodiments, a needle trap or needle receptacle as describedherein is configured such that a user can slide a needle into thereceptacle and have the needle be secured the moment the needle isreleased from the needle driver. The needle can be released using asingle maneuver, and the needle can be immediately secured within theneedle receptacle.

FIGS. 1C-1F illustrate a method of using a suture handling apparatus 305in accordance with embodiments. FIG. 1C shows a surgeon grasping anunused suture needle 103 from a suture pack 101, using a needle driver327 usually held with the user's dominant hand. FIG. 1D shows the needledriver 327 holding the dispensed suture needle 104, having suture 155attached to the trailing end 325 of the suture needle. The leading end323 of the suture needle can be inserted into the tissue 321 near thesite of an incision 317, to install the suture and therefore close theincision. FIG. 1E shows the suture needle 104 having been advanced intothe tissue 321 through the incision 317, to install the suture 155 inthe tissue. The needle driver 327 can be used to grasp the leading end323 of the suture needle 104 as the needle emerges out from the tissue,and pull the needle up and out of the tissue. FIG. 1F shows the surgeonsecuring the suture needle 104, held by the needle driver 327, into aneedle receptacle 331. For example, the user can place the needle 104 inan entry zone 333 of the needle receptacle 331, align the tip of theneedle driver 327 with a slot 343 in the needle receptacle 331, thenmove the needle 104 into a secure zone 337 of the needle receptacle bymoving the needle driver 327 in the direction shown by arrow 329. Asshown by the workflow illustrated in FIGS. 1C-1F, using the apparatus305, a surgeon can dispense a suture needle and securely store thedispensed suture needle by himself, without having to receive a freshneedle passed from, or pass the used needle back to, an assistantlocated outside the near surgical field.

In addition to the improved safety, the inventive system improves theefficiency of surgical procedures, which can result in reduced time forprocedures in the operating room. For example, the time of the surgicalprocedures can be reduced because the scrub tech no longer needs toassist the surgeon with needle loading/unloading, providing needleholders and scissors. Rather than assisting the surgeon, the scrub techcan perform other tasks reduce the time needed in the operating room.For example, the scrub tech can perform a sponge count with thecirculating nurse or begin the breakdown of the back table to facilitatea faster operating room turnover thereby decreasing the time spentbetween surgical procedures. This extra free scrub tech time may alsolead to more accurate and reliable sponge count thereby decreasing therisk of retained foreign object. The overall effect of the inventivesystem and apparatus is faster time of closures (room turnover from onesurgical case to the next) because the scrub tech is also now free tobegin “breaking down” the back table where instruments are kept). Thework flow in the operating room is more efficient because there arefewer steps and no reliance on the support of a scrub tech. Rather thancoordinating the movement of the needles and tools, the surgeon cansimply reach for the needed objects without having to wait for anyoneelse. There is no need to reach for tools and there is no transfer ofsharp objects. The platform can be configured with the properinstruments and/or with needles in an optimum position for removal fromthe suture packs.

Because the surgeon does not need to worry about the coordination oftransferring tools and needles, the surgeon can maintain eye contact onsurgical field. Time lost to looking away from the surgical field orrefocusing the eyes to see where the tools and needles are locatedduring an object transfer can be reduced. Body rotation of the surgeoncan be decreased, as well as crossover of one forearm over the other.The movements can be more circular, of lesser excursion. Thus, themicro-ergonomics can be improved.

Further, the present embodiments can allow the surgeon to track his ownneedle usage and inventory, since the surgeon himself can dispense freshneedles and secure used needles. When needles are passed back and forthbetween a surgeon and an assistant, it can be difficult for the surgeonto know how many more suture needles remain inside an opened suturepack, how many suture packs are opened, etc., while it can be similarlydifficult for the assistant to know how many and/or what types ofneedles have been used by the surgeon. Such lack of clarity regardingthe inventory of available needles can necessitate an ongoing dialoguebetween the surgeon and the assistant, which can be distracting,inefficient, and prone to producing errors. By contrast, when thesurgeon is able to track his own needle usage, as with the methodsdescribed herein, he can easily determine when a particular suture packneeds to be replaced, and communicate his needs to his assistant in amore precise manner. Referring again to FIGS. 1A and 1B, preferably, oneor more new suture packs 101 may be provided on an instrument tray 307(e.g., Mayo stand) located just outside the near surgical field 313. Thesuture packs may be labeled or color-coded to facilitate theidentification of their contents, so that a surgeon can precisely pointout to the assistant which suture pack he needs. The assistant can thenreadily hand the requested suture pack to the surgeon, or the surgeonmay reach for and grab the necessary suture pack himself.

With reference to FIG. 2A, a top view of a suture package 101 isillustrated. The suture package 101 can contain needles 103 threaded orswaged to sutures. The needles 103 can be releasably attached to suturepackage 101 that can include a flat surface that can be flexible to bendto a contour that matches a portion of the user's limbs. FIG. 2Billustrates steri-strips which can be adhesive tape 105 or film that canbe used to secure the suture package 101 to a glove 107 of a user asshown in FIG. 3 which illustrates a top view of a glove 107 and FIG. 4which illustrates a side view of the suture package 101 on the glove107. The adhesive side of the tape 105 can be attached over the edges ofthe suture package 101 and portions of the glove 107.

With reference to FIGS. 5 and 6 another embodiment of the suture package101 is illustrated. In this embodiment, a film adhesive or an adhesive109 applied to the back surface perimeter of the suture package 101.FIG. 5 illustrates a top view and FIG. 6 illustrates a side view of theglove 107 and at least a portion of the perimeter of the suture package101 attached to the glove 107 with the adhesive 109. Alternatively withreference to FIGS. 7 and 8, an adhesive 111 can be applied directly tothe back of the suture package 101. FIG. 7 illustrates a top view of thesuture package 101 and FIG. 8 illustrates a bottom view of the suturepackage 101 with the adhesive 111 applied. In all of these examples, theadhesive that can be used to attach the suture package 101 directly tothe glove 107.

FIG. 9 illustrates a front view and FIG. 10 shows a top view of anembodiment of a “C” shaped holder 113 that can be used to hold suturepackets 101. The “C” shaped holder 113 can wrap around a portion of theuser's hand as shown in FIGS. 11 and 12. FIG. 11 shows a top view andFIG. 12 illustrates a side view of “C” shaped holder 113 on a glove 107on the user's hand. The holder 113 can be made of a flexible materialthat inherently retains its C shape and includes a clip 115 on an outersurface. The holder 113 can be placed on the hand and a suture package101 can be attached to the clip 115, which can include a spring and ahinge 117. The clip 115 can hold the suture package 101 in place so thatthe needles 103 can be grasped with the needle driver as describedabove. If the user runs out of needles 103, the original suture package101 can be removed from the clip 115 and replaced with a new suturepackage 101 with additional needles 103.

FIGS. 13 and 14 illustrate another embodiment of the suture package 101system, which can include a platform 119, and straps 121 that wrap atleast partially around the glove 107 on the user's hand. FIG. 13 shows atop view and FIG. 14 illustrates a side view of the platform 119, andstraps 121 that wrap at least partially around the glove 107. The suturepackage 101 can be attached to the platform 119 in various ways, such aswith an adhesive, straps, etc. The needles 103 can be grasped asdescribed above. If the user runs out of needles 103, a new suturepackage 101 can be attached to the platform or the used platform can bereplaced with a new platform having additional needles 103.

With reference to FIGS. 15 and 16, in another embodiment, a magneticsystem can be used to secure the suture pack 101 to the glove 107. FIG.15 shows a top view and FIG. 16 illustrates a side view of the magneticsystem used to secure the suture pack 101 to the glove 107. A firstpermanent magnet 123 can be secured to the glove 107 and a correspondingpolarity permanent magnet 125 can be attached to the suture pack 101.The polarities of the permanent magnets 123, 125 can be arranged so theback of the suture pack 101 is attracted to the glove 107. The magnets123, 125 can be attached to the glove 107 and suture package 101 withany suitable connection mechanism including adhesives, pockets, clips,etc. When the suture pack 101 runs out of suture needles, the surgeoncan remove the empty suture pack 101 by pulling the suture pack 101 witha force greater than the magnetic force and placing a new full suturepack 101 on the magnet 125.

With reference to FIGS. 17 and 18, the suture pack 101 can includemultiple layered sheets of materials with each sheet holding a set ofneedles 103 and sutures. FIG. 17 illustrates a top view and FIG. 18illustrates a side view of the multiple layered suture package 101. Thismultiple layer suture package 101 can be attached to the glove 107 asshown in FIGS. 19 and 20 in any manner described above. FIG. 19illustrates a top view and FIG. 20 illustrates a side view of themultiple layer suture pack 101 attached to the glove 107. The user canuse the needles 103 on the top layer of the suture package 101. Whenthese first layer needles 103 are used, the user can remove and discardthe depleted top layer suture package 101. The underlying layer can thenbe exposed and the needles 103 stored on the second layer of the suturepackage 101 can be used. This process can be repeated until all of thelayers of the suture package 101 are used.

In an embodiment shown in FIGS. 21-24, a suture pack 101 can have a hookand loop connection mechanism to couple the suture pack 101 to the glove107. FIG. 21 illustrates a top view of the suture pack 101 and FIG. 22illustrates a side view of the suture pack 101. In this embodiment, ahook or loop material can be attached to the back of the suture package101 and a corresponding loop or hook material can be attached to theouter surface of the glove where the suture package 101 is to beattached. In the illustrated embodiment, the hook material 127 isattached to the bottom of the suture package 101. FIG. 23 illustrates aside view of the loop material 129 and FIG. 24 illustrates a bottom viewof the loop material 129 with an adhesive 131 applied to the back of theloop material 129. FIG. 25 illustrates a top view and FIG. 26illustrates a side view of the suture pack 103 attached to the glove 107with the hook and loop connection mechanism. When the needles 103 in thesuture package 101 are depleted, the suture package 101 can be replaced.

In an embodiment shown in FIGS. 27 and 28, a needle storage unit 133 canbe secured to the hand in addition to the suture package 101. Theoperating efficiency can be further improved by having the suture packs101 and used needle storage unit 133 in close proximity to the surgeon.The platform 145 can be attached to the non-dominant limb of thesurgeon. The surgeon can then grasp a needle 103 and suture from asuture packet 101 on the platform 145. The surgeon can install thesuture on the patient and then place the used needle 104 in the usedneedle storage unit 133. The surgeon can then grasp the new sutureneedles 103 from the suture packet 101 on the platform 145 worn on thenon-dominant limb.

The needle storage unit 133 can hold the used needles 104 after thesuture has been knotted and the needle is no longer needed. The needlestorage unit 133 eliminates the need to place the used needle 104 in theneutral zone and picked up by the surgical staff after it has been used.The user can simply complete the suture stitch, cut the suture and placethe used needle 104 in the needle storage unit 133 with the needledriver. The user can then grasp the next needle 103 from the suturepackage 101. The needle storage unit 133 can greatly increase theefficiency of the surgical procedure. In an embodiment, the needlestorage unit 133 can include an internal volume and internal walls witha hole or slot for inserting the used needles 104. The housing may betransparent so the user can see that the used needles 104 are fullyinserted and trapped within the needle storage unit 133.

With reference to FIGS. 29 and 30 elastic bands 135 can be used tosecure the suture package 101 to the glove 107 or wrist of the user. Theelastic bands 135 can be a uniform loop or elongated structures thathave a connection mechanism such as a strap buckle or a hook and loopconnection so that the tension of the elastic bands 135 can be adjustedaround the user's hand and/or arm. The bands 135 can be attached toopposite edges of the suture package 101 as shown in FIGS. 31 and 32.

In an embodiment, the suture package 101 can be held in a pocket 137 inthe glove 107 as shown in FIGS. 33 and 34. The suture package 101 can beplaced into the pocket 137 through a slot 139 so that at least thepocket material covers some of the suture package 101. A window 141 orwindows can be formed in the pocket so that the needles 103 areaccessible. The pocket 137 can securely hold the suture package 101 andallow a user to remove the needles 103 from the suture package 101 asdescribed above. If additional needles 103 are required, the suturepackage 101 can be removed from the glove pocket 137 and replaced with anew suture package 101.

In an embodiment shown in FIGS. 35 and 36, the suture package 103 caninclude multiple layers that each holds a set of needles 103. The layerscan be attached to a hinge unit 106 so that the user can flip throughthe different layers like a “Rolodex.” As discussed above, there aremany different types and shapes of needles 103. In an embodiment,different needles 103 can be stored on the different layers of thesuture package 102. With reference to FIG. 37, the multi-layered suturepackage 102 can be attached to the glove 107 in any of the waysdescribed above. For example, a bottom layer of the suture package 101can be held in a slot 139 pocket formed in the glove 107. A mechanismsuch as a hook and loop connection can be used to hold the bottom layerin the pocket.

As discussed above with reference to FIGS. 13 and 14, a platform havinga suture package can be attached to a glove on a hand. In otherembodiments, the platform can include various other componentsincluding: tool holders, suture packs and used needle holders. Forexample with reference to FIG. 38 a top view of a multiple componentplatform 145 is illustrated. The platform 145 can include a first toolholder 147 for holding a first tool 151 and a second tool holder 147 forholding a second tool 151. During a procedure the surgeon can insert afirst tool 151 into a first tool holder 147 and remove a second tool 151from a second tool holder 147. Because the first and second tools 151are easily accessible, there is no need for an assistant to handle thetools 151 as the surgeon switches between the tools 151. A suture pack101 holding suture 103 and a used needle storage unit for storing usedneedles 104 can also be attached to the platform 145.

In an embodiment, the tools 151 can be needle drivers that have handleat a proximal end and a thin tip at a distal end. The tool holders 147can be holes or slots that are wider than the distal portion of the tool151. The distal ends of the tools 151 can be inserted into the holders147 in the platform but the handle portions of the tools 151 can bewider than the holes or slots. The center of balance of the tools 151can be inserted through the holes or slots so that when the platform isupright, the tools 151 will be held in the tool holders 147. In anembodiment, the slots can be between about 0.5 to about 2.0 inches inwidth.

A surgeon can use a platform for holding suture packages during amedical procedure. The suture holders can be attached to a platform 145that is secured to the glove 107 around the hand/arm 143 of the user. Inan embodiment, the platform 145 can be much larger than a single suturepackage 101. In these embodiments, multiple suture packages 101 can beattached to different areas of the platform 145. A surgeon can have aplurality of suture packages 101 on the dorsal surface of the left handglove 107. The right hand is holding a needle driver, which is holding aneedle. The right hand is also holding a tool. The surgeon can completea stitch and then release the needle. The needle driver can grasp a newneedle from the suture package 101.

FIG. 38 illustrates a top view of an embodiment of a platform 145secured around an arm that includes modular attachments. In thisexample, a tool holder 147, suture package 101 and a used needle holder149 are mounted on the platform 145. FIGS. 39-41 illustrate side viewsof different embodiments of platforms 145 that are secured to arms 143of surgeons. FIG. 39 illustrates a side view of an embodiment of theplatform 145 with the tool holder 147, suture package 101 and a usedneedle holder 149 are mounted on the platform 145. The platform 145 canbe a thin structure that can have planar surfaces for mounting themodular attachments in any locations desired by the surgeon. The portionof the platform 145 that is on the forearm 143 can be secured close tothe dorsal surface up the wrist portion of the arm 143. However, theplatform 145 may also include a wrist and hand portion 146 that isangled away from the upper dorsal surface of the hand 144. This spacedconfiguration allows the user to move the hand 144 freely withoutcontacting the bottom surface of the platform 145. In an embodiment, thebottom surface of the platform 145 can be between about 1 to 4 inchesaway from the upper surface of the hand 144 in the normal straightposition.

FIG. 40 illustrates a side view of a platform 145 with a first suturepackage 101, a used needle holder 149, a second suture package 101 and aswaged needle holder 153 with an attached suture. In this example, theswaged needle holder 153 can be include a permanent magnet that holdsthe needle temporarily and the end of the needle 103 can protrude fromthe needle holder 153 so the needle 103 can be easily grasped again. Thesurgeon can place the needle 103 on the swaged needle holder 153,release the needle 103 and tie the suture 155. The surgeon can thengrasp the needle 103 with the needle driver and insert another stitchthrough the patient and repeat the described process. The platforms 145can have various different curvatures so that a surgeon can select aplatform 145 that best suits the personal preference. FIG. 41illustrates a side view of a platform 145 having a substantiallydifferent size and curvature shape.

Different structures can be mounted on the platforms 145 depending uponthe preference of the surgeon. For example with reference to FIG. 40,the platform 145 can include a two suture packages 101 arranged side byside and a needle container 149 on the hand portion of the platform 145.Using the illustrated platform, the surgeon can select different typesof needles and then place the used needles 104 in the needle container149 after each is used. The surgeon can then grasp additional needles asthey are needed. Alternatively in other embodiments, the platform 145can include a suture package area on the proximal portion of theplatform 145, a tool holder at a wrist portion of the platform 145 and aneedle container 149 on the hand portion 146 of the platform 145.

As discussed above, the surgeon can place used needles 104 into theneedle container 149 and then use a second tool as needed. FIGS. 42-47illustrate different embodiments of the used needle holders. It isextremely important to account for all needles during the surgicalprocedure. If a needle becomes lost during the surgery, the needle mustbe found and it may become necessary to x-ray the patient to determineif the needle has been left within the body. The used needle holder canprovide various features, which can make the used needle count easier.

FIG. 42 illustrates a top view and FIG. 43 illustrates a side view of anembodiment of a used needle holder 149 having a plurality of individualneedle receptacles 157. Each receptacle 157 can include a conical holethat can easily accept the tip of the needle 104. The lower portion ofthe conical hole can clam around the sides of the needle 104. Thismechanism can allow the needle 104 to be inserted but prevent the needle104 from being removed. The needle holder 149 can also include anelastic material that can allow a needle 104 to be pressed into thematerial but may resist the movement/removal of the needle 104. Theneedle holder 149 may also include a magnet, which can attract theneedle 104. These features can be mixed and matched or omitted in anycombination to provide an effective means for holding used needles 104.The surgeon can press the needles 104 fully into the used needle holder149 and release the needle 104. Once fully inserted the needle holder149 will not release the used needles 104. The surgeon can preferablyinsert the used needles 104 sequentially. The number of needles 104 caneasily be counted. In this example, needle receptacles 157 are arrangedin two rows of 10 receptacles 157. In other embodiments, any otherreceptacle configuration can be used and the receptacles 157 can belabeled with numbers.

FIG. 44 illustrates a top view and FIG. 45 illustrates a side view of anembodiment of a used needle holder having a tapered needle receptacle161 and a permanent magnet 163 mounted on a base 164. The needles 104are held at a proximal end with a needle driver and the surgeon canplace the tips of the used needles 104 into the side opening of the usedneedle holder. The needles 104 can be placed flat against the permanentmagnet 163. The magnet 163 can provide a raised needle holder surface sothat the proximal end can be held until the needle 104 is held flatagainst the permanent magnet 163. The surgeon can then release theneedle 104 knowing that the used needle 104 is securely in the usedneedle holder 161. The used needle holder 161 can be constructed ofclear plastic so that the number of used needles 104 in the used needleholder 161 can be seen and counted.

FIG. 46 illustrates a top view and FIG. 47 illustrates a side view ofanother embodiment of a used needle holder 165. The needle holder 165can include a housing that has an interior volume and a needle slot. Thesurgeon can align the used needle 104 with the slot 167 and insert theneedle 104 into the housing with the needle driver approximatelyperpendicular to the length of the slot 167. The surgeon can then rotatethe used needle 104 so that it is out of alignment with the slot 167 andplace the needle 104 against a permanent magnet 163 within the housing.The magnet 163 can provide a raised needle holder surface so that theproximal end can be held until the needle 104 is held flat against thepermanent magnet 163. The surgeon can then release the used needle 104and remove the needle driver. The used needle 104 will be held againstthe permanent magnet 163 and even if the needle 104 comes loose it willbe held within the needle holder 165 housing.

In an embodiment, a platform can be used by the surgeon to hold tools,sutures, needles, suture packs, sharps container, etc. The platform canbe secured to a forearm and/or hand and/or forearm and/or fingers on oneor more dorsum surfaces of the surgeon so that the objects can be easilyaccessed without the need for any interaction with anyone else such as ascrub technician. Thus, when using the platform, the surgeon does notneed to interact with anyone else. The surgeon can remove objects fromthe platform that are needed and place and store objects on the platformthat are no longer needed. The elimination of interaction betweenmultiple individuals to handle the sharp objects simplifies the surgicalprocedure and reduces the chances of cuts or other injuries such aslacerations, punctures, abrasion, break in the skin, etc.

In an embodiment with reference to FIGS. 48 and 49, the inventiveplatform 145 can have a multi-layered construction. The main structuralelement can be a structural layer 169 which can be malleable and mayalso function as a barrier. The ability to plastically deform thestructural layer 169 can allow the surgeon to easily adjust the shape ofthe platform 145 to provide any desired fit and configuration. Anexample of a suitable structural layer 169 material can be aluminum andaluminum alloys which provides a durable, lightweight, ductile andmalleable metal material. The thickness of the aluminum structural layer169 can be between about 0.01 and 0.10 inches. Any portion of thealuminum structural layer 169 can be easily bent by hand into thedesired shape resulting in plastic deformation so the structural layer169 will retain the bent shape. In other embodiments, any other materialthat has similar characteristics can be used.

In addition to providing a stable platform 145 for tools and objects,the structural layer 169 can also provide a protective barrier for thesurgeon from sharp objects. If a surgeon accidentally directs a sharpobject towards the dorsum of the forearm, the structural layer 169 ofthe platform 145 will block the sharp object and prevent any injury tothe portions of the forearm and wrist and hand covered by the platform145. Aluminum is a material that is softer than steel. Thus, a tool orsharp object that is pressed against the structural layer 169 will tendto not be scratched or otherwise damaged by the contact with the softerstructural layer 169 material.

FIG. 48 illustrates a side view of a multi-layer platform 145. A loweror inner surface of the structural layer 169 can be bonded to an innerelastic foam layer 171. When the platform 145 is attached to the forearmof the surgeon, the inner foam layer 171 can be placed on the forearmand hand dorsum of the surgeon. The inner foam layer 171 can have aporous open cell structure. Because the foam does not contain gasbubbles, it can be more compressible than closed cell foams. However,both closed and open cell foams can be used. The inner foam layer 171can provide improved comfort and conformability. The elasticity of theinner foam layer 171 allows the structural layer to be bent as describedabove. A suitable inner foam material is natural rubber latex.

As shown in FIGS. 48 and 49, the structural layer 169 can includebendable legs 175 that extend outward from the sides of the platform145. These legs 175 can be bent to wrap around the forearm of thesurgeon. The inner foam layer 171 provides a conforming fit to variableanatomy that is securely attached to the forearm. The inner foam layer171 also provides a comfortable padded surface that disperses thecompressive forces of the legs on the forearm. Because the malleablestructural layer 169 is plastically deformed to any shape, the legs ofthe platform 145 can be accurately fitted to any forearm. Because therecan be various configurations and sizes that best suit specificapplications, the size and shape of the platform 145 can be any suitabledimensions. The inventive platform is not limited to the illustratedembodiments.

With reference to FIGS. 50-53, various shape multi-layer embodiments ofthe platform 145 are illustrated. These multi-layer platforms 145include a structural layer 169 secured to an inner layer 171 and anouter layer 173. Legs 175 can extend from the platforms 145 and wraparound the surgeon's arm 143. In the illustrated embodiments, thesurface area and shape of the platform 145 over the hand portion of thearm 143 can vary dramatically. The inventive platform 145 is not limitedto the illustrated embodiments. With reference to FIG. 53, themulti-layer platform 145 with legs 175, an inner layer 171, a structurallayer 169 and an outer layer 173. The platform 145 is illustrated with atool holder for holding tools 151, suture pack holder for holding suturepacks 101 and a used needle holder 149 for holding used needles 104.

Although the inner elastic foam layer has been described as being bondedto the structural layer, there can be portions of the inner foam layerthat are not bonded to the structural layer. For example, in someembodiments, the platform can include tool holders that are located atholes formed in the structural layer. The tools such as needle driverscan be placed in the holes with the thin body of the needle driverdistal to the tool finger holes. The thin body can be placed through thehole while the handle finger holes of the needle driver cannot passthrough the hole because it is wider than the diameter of the hole.Thus, the handle will hold the tool in place and prevent it from passingcompletely through the hole. The holes can be oriented such as toproperly orient the tools for easy grasping by the contralateral hand.For example the holes may be oriented as slots with the long axisparallel or at a specific angle to the long axis of the forearm suchthat the finger loops of the needle holder can be easily grasped by thecontralateral hand without the need for contralateral forearm motion. Inan embodiment, the tools are held in the tool holders of the platformwith the structural layer between the center of gravity of the tool andthe handle or finger hole portion of the tool. As discussed, the innerand/or outer foam layers that are bonded to the structural layer canprovide friction which can prevent the movement of the tool. Thus, thetools can be held in the tool holders by a combination of gravity andfriction.

In some embodiments, the upper and lower foam material adjacent to theholes is removed. However, in other embodiments, the foam layers can beleft over the holes. For example with reference to FIG. 54, in the innerfoam of the tool holder holes, a smaller hole 177 can be formed withinan hole 179 in the barrier material. The tool can be pressed through thesmaller hole 177 and because the inner foam is elastic, the smaller hole177 can expand as the tool is pressed through the hole 177. The staticfriction of the expanded foam hole 177 circumference which is in tensionagainst the sides of the tool can prevent accidental removal of the toolfrom the platform. The foam can also act as a dampening device thatprevents the tools from knocking or sliding against the inner diameterof the hole 179 in the structural layer which can create noise andvibrations. This dampening feature can be important during delicatesurgical procedures.

It is also possible to have a smaller hole 178 (FIG. 55) or larger hole178 (FIG. 56) formed in the upper outer layer foam over the tool holes179 in the barrier layer. Again, the upper layer foam can provide afriction force that can hold the tools in the tool holes 179. In yetother embodiments with reference to FIG. 57, the upper and lower foamlayers may have smaller holes 177, 178 that are not aligned with eachother. By offsetting the alignment the foam layers can cause the toolsto be angled relative to the platform. This can provide more clearanceso the ends of the tools are not rubbing against the forearm of thesurgeon.

In other embodiments the inventive surgical platform can include anotherouter elastic foam layer that is bonded to the outer surface of thestructural layer opposite the inner surface. The outer foam layer canhave different physical properties than the inner foam layer. Asdiscussed above, the platform can be used to hold tools, sutures, suturepacks, needles, sharps containers, etc. The sharps containers caninclude various embodiments including: sponges, enclosures, magnetizedsurfaces and/or combinations of different embodiments. In an embodimentthe outer foam layer can have physical characteristics that will improvethe connection between the objects and the platform. For example, theouter surface of the outer foam layer can have a greater surface areafor better anti-slip surface that provides a high static coefficient offriction with the objects that effectively grip the contact surfaces ofthe object.

In an embodiment with reference to FIGS. 58-63, the structural layer 169can have tabs 181 that can be bent upward from the plane of thestructural layer 169. An object 108 such as a suture pack can be placedadjacent to one or more of the tabs 181 and the tabs 181 can be bentover an exposed surface of the object 108 to hold the object 108 againstan edge of the outer foam layer 173. As discussed, the malleablestructural layer 169 material may be plastically deformed and the benttabs 181 can hold the object 108 against the platform 145. Thehorizontal force of the tab 181 against the object 108 can cause acompressive force between the object 108 and the outer foam layer 173 asshown in FIG. 64.

It can be very important to hold objects 108 in a secure manner to theplatform 145. In an embodiment, the outer foam layer 173 can be a highfriction material that prevents or resists movement between the object108 and the outer layer 173. The friction force between the objects 108and the outer surface of the outer foam layer 173 can be described orquantified based upon the static coefficient of friction (COF), whichcan be symbolized by the Greek letter μs. The static COF is adimensionless scalar value that describes the ratio of the force offriction between two bodies and the force pressing them together. Thecoefficient of friction depends on the materials used. For example,slippery materials such as Teflon on smooth surfaces can have a lowcoefficient of friction, while rubber on a suture package surface canhave a higher coefficient of friction. Coefficients of friction rangefrom near zero to greater than one. In an embodiment, the staticcoefficient of friction between the outer surface of the outer layer 173of foam and the object 108 coupled to the platform is greater than 0.3.The friction force is quantified by the static friction=μs×compressionforce.

The compression force can be applied by a clamp, a tab 181, elasticmaterial, a clip, a spring and/or any other suitable mechanical device.The compression force can also be provided by the foam. The compressionforce can be stored in the foam material by manually bending the tab 181over and onto the suture packet. The compressed foam will try to expandand this foam expansion force can help to hold the suture packet inplace. The compression force can prevent any vertical movement of thesuture packet and the friction force can prevent any horizontal movementrelative to the platform surface. In an embodiment, the compressionmechanism is attached to the platform and applies a force to compressthe object against the outer foam layer. The compressive force resultsin a friction force that prevents a sliding movement of the object overthe surface of the outer foam layer.

With reference to FIG. 49, in an embodiment, the outer foam material 173can provide a functional structure. For example, after needles are usedthey must be stored and accounted for. In an embodiment, a portion suchas the used suture needle region 192 of the outer foam 173 can be markedwith individual needle regions. Each of the individual needle regionscan be marked with a number 259 and adjacent needle regions can bemarked with sequential numbers 259. As the needles 103 are used, thesurgeon can place the used needles 104 in the used needle region 192. Afirst used needle 104 can be placed in a region marked 1, a second usedneedle 104 can be placed in a region marked 2, etc. The outer foam 173can be made of a thick material that allows the needles 104 to besecurely captured until the surgical procedure is completed. Because theneedles 104 are placed in numbered 259 regions, it is easy to visuallyaccount for all needles 104 used during the surgery by simply looking atthe numbers 259 in the used needle regions 192.

The described sharps container 255 can provide various benefits to theusers. The sharps container 255 is easily accessed and secured to anyportion of the platform 145 over the forearm and hand. The used needles104 are highly visible in the repository for easy used needle 104counting. The demarcations can assist in the counting of the usedneedles 104. The foam 173 in the sharps container securely holds thetips of the needles 104. The tips are also adjacent to the structurallayer 169 and cannot cause damage even if the needles 104 areaccidentally contacted or pressed further into the foam 173. The usedneedles 104 can be secured, treated and maintained in control of thesurgeon until a “group transfer” occurs. More specifically, the usedneedles 104 are secured to the sharps container 255. The used needles104 can also be treated by mechanically cleaning the distal portions andchemically disinfected. The securing of the used needles 104 can be inconstant contact and can be maintained in control of the surgeon until a“group transfer” occurs. The “group transfer” can include the transferof a group of surgical tools from the surgeon to the scrub tech. Thesurgical tools in the group transfer can include: the needle driver, theforceps, the used sharps container, the sharps container and otherobjects.

In an embodiment, outer foam layer 173 can include different areas thathave different physical properties. For example, first area may bedesigned to support suture packs 101 and a second area may be designedto function as a sharps container 255 as described above. The first areathat supports the suture packs 101 can be made of a thinner less elasticfoam material with a higher COF exposed surface than the second area.The suture packs 101 can be compressed against the first area and thehigh COF can prevent movement of the suture packs. This feature can beimportant because the surgeon must manually place the proximal ends ofthe needles 103 in needle driver. Any unwanted movement of the needles103 can make this task more difficult.

With reference to FIGS. 58-59 in an embodiment, the structural layer canhave one or more tabs 181 that can be used to secure objects to theplatform 145. The outer foam layer 173 can be removed from thestructural layer 169 which can be exposed. Bendable tabs 181 can beformed in a suture pack carrier 183 area of the exposed structural layer169. These bendable tabs 181 can be cut in the structural layer 169 andcan remain planar with the structural layer 169 before being used. Thetabs 181 can be arranged in a staggered manner so that objects such assuture packs can be secured to the suture pack carrier 183 area of thestructural layer 169 with the tabs 181 that most closely fit theobjects.

FIG. 58 illustrates a suture pack carrier 183 before suture packs 101are secured and FIG. 59 illustrates a suture pack carrier 183 aftersuture packs 101 have been secured. For example, a suture pack or suturepacks 101 may be substantially planar rectangular structures that areheld to the platform with the tabs 181. The suture packs 101 can beplaced on the platform 145 and the tabs 181 can be bent up and over onemore side edges of the suture packs 101. The suture packs 101 can comein various different sizes. Thus, the suture pack carrier 183 on theplatform 145 can have multiple tabs 181 can be set in differentlocations to accommodate the variety of suture pack 101 sizes.

With reference to FIGS. 60-63 in other embodiments, multiple suturepackets 101 can be stacked over the same suture packet carrier 183. FIG.60 illustrates a suture pack carrier 183 before suture packs 101 aresecured and FIG. 61 illustrates a suture pack carrier 183 after multiplelayers of suture packs 101 have been secured. FIG. 62-63 illustrate asuture pack carrier 183 after multiple layers of suture packs 101 havebeen secured and some suture packs 101 have been removed. Different tabs181 can be used to hold each of the layered suture packets 101. Afterall needles 103 of a suture packet are removed, the suture packet 101can be removed to expose the underlying suture packet 101. In apreferred embodiment, the surgeon can grasp a side of upper depletedsuture packet 101 with the needle driver and remove it from the suturepacket carrier 183. The underlying suture packet 101 will then beexposed and the needles 103 will be accessible to the surgeon. Thisprocess can be repeated until the bottom suture packet 101 is exposedand all necessary needles 103 are used by the surgeon.

In the illustrated embodiment, the tabs 181 hold one or more of thesuture packs 101 to the platform 145. Some of the tabs 181 are orientedto be substantially perpendicular to the edges of the suture packets 101while other tabs 181 can be oriented at various other angles. In theillustrations, the tabs 181 on the lower right are oriented to be about45 degrees to the side edges of the suture packets 101.

In an embodiment, the multi-layer platform can have a suture packcarrier. FIGS. 64-67 illustrates side views of various suture packcarriers 183. With reference to FIG. 64, the upper foam layer 173 can bepartially removed from some areas of the platform which can expose thestructural layer 169. The objects, such as a suture pack 101, can bepressed against the edges of the upper foam layer 173. This force on theobject can compress the object into side of the upper layer foam 173.The compression force creates a friction force that can hold the edge ofthe object to the platform adjacent to the structural layer 169. One ormore sides of the object can be compressed into different surfaces ofthe upper foam layer 173. One or more tabs 181 can be secured over thesides of the object opposite the side of the object pressed into theupper layer foam 173.

In the illustrated embodiments, the suture pack retaining structures canadapt to wide range of suture pack 101 sizes. Suture packs 101 can varyin size from about 1″×3″ to about 3″×4″. The suture packs 101 can have a“flat” conformation. The tabs 181 can provide an easy and secure systemfor attaching or locking the suture packs 101 onto the barrier platform.The platform can accommodate multiple suture packs 101 and the packs canalso be easily removed from the platform.

With reference to FIG. 65, in an embodiment, the tabs 181 can extendthrough the upper foam layer 173. The suture pack 101 can be placedbetween the tabs 181 and the ends are bent over the edges of the suturepack 101 to hold it against the upper foam layer 173. With reference toFIG. 66, in an embodiment, the upper foam layer 173 can be partiallyremoved. Tabs 181 can be wrapped over the edges of the suture pack 101to hold it against the structural layer 169.

With reference to FIG. 67, in yet another embodiment, holes that areslightly smaller than the perimeter shape of the suture packs 101 areformed in the upper foam layer 173. The suture packs 101 can be pressedinto the holes until they are against the structural layer 169 or thelower surface of the hole. The compression of the suture packs 101 maycause them to bow upward. In order to prevent this motion, fasteners 185can be placed in a center portion of the suture pack 101 to hold it inplace. In other embodiments, where the suture pack 101 is made of astronger material that does not deform under compression, the fastener185 may not be necessary.

The inventive platform has been described with various systemcomponents: tool holders, tools, suture pack holders, suture packs,armed needles, used and sharps containers, all mounted on a platform.Although these components can be set at predetermined locations on theplatform, in other embodiments, the inventive system can have a modularconfiguration. In these embodiments, the system components: toolholders, tools, suture pack holders, suture packs, armed needles 103,sharps container can be independent and modular. The user can mix andcombine these individual components and place them in any desiredpositions on the apparatus and platform. The individual components canhave various connection mechanisms such as: hook and loop (Velcro),snaps, tack features, screw fasteners, tabs, or any other suitableconnection mechanisms such as elastic bands and adhesives. Once thesurgical procedures are completed, the system components can be removedfrom the inventive platform. It may be possible to clean and sterilizethe platform, attach new modular components and reuse the platform.

The present platform invention can address several operating room issuesincluding improved safety and efficiency. As discussed, the structurallayer of the platform can create a barrier that prevents needle sticksto forearm and dorsum of hand. Thus, both the surgeon's hand and forearmcan be protected. The platform can be held against the forearm but canbe spaced away from the hand, which may allow for full movement of thesurgeon's (wrist, hand, fingers) hand. The platform also does notinterfere with the elbow range of motion.

The inventive platform system provides various benefits. The bendablelegs allow the platform to adapt readily and securely to variableforearm sizes. The platform allows the surgical tools and needles to beoriented in any desired position. Ideally, the system can minimizeunnecessary forearm motion. The suture pack(s) can be placed on anyportion of the platform including the radial border of forearm and thevolar forearm. The platform provides a protective barrier to the handand forearm while still allowing full hand range of motion. The angle ofthe hand cover portion of the platform relative to forearm portion canbe about 10-45 degrees. However, the hand element can be flexible andthe angle and shape of the hand element can be adjusted to any desiredshape. The inflection point may be: a living hinge, a mechanical hingeor any other suitable articulation movement mechanism.

For example, with reference to FIGS. 88 and 89, a multi-layer platformis illustrated that includes a movable inflection point 207. When thehand is in a straight position, the platform can assume a normal shape.However, then the hand is moved up relative to the forearm, the hand cancontact the bottom of the portion of the platform and the hand portion146 of the platform can rotate with the hand as shown in FIG. 89.

In preferred embodiments, the sharps container can be physicallyadjacent to or in close proximity with the suture packet holder and thesuture packets. The sharps container and the suture packets can be onthe same support structure such as a platform. This configurationfacilitates improved surgical work flow and condenses several complexcoordinated motions into more streamlined simplified actions performedby the surgeon. As discussed, the platform with the suture packetholders secured to suture packets and the sharps container can be on thesame platform apparatus mounted on a non-dominant arm of the surgeon.When a suture is required, the surgeon can grasp an armed needle havingan attached suture from the suture packet and use the suture on thepatient. When the stitch is completed, the surgeon can then place theused needle in the sharps container and then easily grasp a new armedneedle from the suture packet.

Various sharps container designs can combine with the inventive system.In an embodiment, the sharps container can be a soft open or closed cellelastic material such as foam or a sponge which can be marked with asequence of numbered regions. The used needles can be inserted into thesoft cell material which will hold the used needles in place. In anembodiment, the sharps container cell material can be adjacent or bondedto one or more layers of a thin elastic homogeneous material such as asoft plastic or rubber that can be easily pierced by the used needleswithout substantially deforming the soft elastic cell material. Thehomogeneous material can provide a friction force that can increase theresistance to inserted needle movement that can further prevent theaccidental removal of the used needles from the sharps container. It canalso be easier to print the number markings on a solid rubber materialthan on a soft elastic cell material such as foam.

A potential problem with used needles is their ability to transmitviruses when a used needle accidentally breaks the skin on an operatingroom surgical member. However, if the used needle is cleaned and/ordisinfected the used needles are much less likely to spread viruses. Inyet another embodiment, the soft open or closed cell elastic materialcan be coated and/or saturated with a disinfectant such as bleach orother antimicrobial materials. The disinfectants can be in the form of ahigh viscosity gel that can be held within the foam material but willnot easily be removed from the elastic cell material. In an embodiment,a portion or all of the soft open or closed cell elastic material of asharps container can be surrounded by a layer(s) of the thin elastichomogeneous material in order to help retain a disinfectant liquidwithin the soft cell sharps container material (may need to elaborate,clarify).

With reference to FIGS. 102, 103 the inventive system can clean anddisinfect the used needles 104 as they are inserted into the soft openor closed cell elastic material 251, 253. As the used needles 104 piercethe soft cell material 251, 253 and/or the solid elastic materiallayer(s) 250, 252, that can be cleaned by wiping the outer surfacesagainst these materials. The used needles 104 can be disinfected whenthey are exposed to the disinfectant. Thus, if any of the used needles104 are accidentally removed from the described sharps container 255,they are cleaned and disinfected and are much less likely to spreadviruses.

With reference to FIGS. 96-99 in other embodiments, the sharps container235 can include an enclosure having a door mechanism 237 that is openedto received used needles and closed to prevent used needles from exitingthe sharps container 235. Different mechanisms can be used to controlthe position of the door 237. For example, in an embodiment, theposition of the door 237 can be manually controlled with a switchmechanism. The door control mechanism can be coupled to a spring 245which can hold the door 237 in the closed position and a manual actuatorsuch as a lever 243. When user presses against the lever 243, the spring245 can be compressed and the door(s) 237 can be open. The user can dropthe used needles into the repository and the release the lever 243 toclose the door 237.

In the illustrated embodiment, the door 237 mechanism is coupled to apair of rotational members 246 on opposite sides of the sharps container235. A lever 243 can extend away from the receptacle housing. When noforce is applied to the lever 243, a torsional spring 245 or any othersuitable spring mechanism can exert a counter clockwise torque about oneor both of the rotational members 246. This torque can hold the door 237in the closed position against a stop 247. When a downward force isapplied to the lever 243, a clockwise torsional force can be applied tothe door 237 mechanism that is greater than the counter clockwise spring245 force. The door 237 mechanism can rotate clockwise and open to allowused needles 104 to be deposited in the receptacle 235. Once the usedneedle 104 is captured, the use can release the lever 243 and the door237 can return to the closed position against the stop 247.

The manually controlled door configuration can allow the user tocarefully control the door 237 to prevent used needles from escaping thesharps container 235. The repository housing can include an opening atthe top surface and the door 237 mechanism can be mounted on tworotational members 246 on opposite sides of the housing that define arotational axis. The doors 237 can be above the rotational axis 246 anda spring 245 can normally hold the door 237 in a closed position againsta rotational stop 247. The lever 243 can be coupled to the door 237mechanism and exit a side of the housing that is easily accessible tothe user such as the side of the housing closest to the user. Actuatingthe lever 243 can cause the door 237 mechanism to rotate about therotational axis and open. When the lever 243 is released, the spring 245will rotate the door 237 mechanism back to the closed position.

With reference to FIGS. 100 and 101 in an embodiment, the door 237 canbe coupled to an automatic control system 249 which includes anaccelerometer(s), a processor, a power supply and an actuator. Theaccelerometer(s) can detect the orientation of the needle receptacle 235based upon the gravitational forces. When the accelerometers detect thatthe needle receptacle 235 is substantially upright in position, theprocessor can control the actuator to open the door 237 and when theneedle receptacle is not properly oriented, the processor control theactuator to close the door 237. In an embodiment, the system can beprogrammed or set to open the door 237 at a specific range oforientations that can correspond to the optimum limb or tool positionswhich can allow for the needle to be dropped into the receptacle 235.The system can also detect abnormal situations which can indicate anaccident. For example, if the detected acceleration is significantlygreater than the gravitational force, the system can interpret this asan accidental impact with the sharps container and the processor cancontrol the actuator to close the door 237.

Alternatively the position of the door can be automatically controlledby gravity. When the sharps container is used on a forearm-mountedplatform, the door can be at the top of the repository and open when therepository is in an upright position. However, when the sharps containeris rotated, the doors can close to prevent used needles from exiting.

FIGS. 92-95 in an embodiment, the repository housing 235 can include anopening at the top surface. The door 237 mechanism can be mounted on tworotational members 246 on opposite sides of the repository housing 235that define a rotational axis. The doors 237 can be above the rotationalaxis and a counter weight(s) 239 below the rotational axis. The door 237mechanism can open when the repository housing 235 is upright relativeto the rotational axis within a range of about 0 to 30 degrees. Atrotational positions greater than 30 degrees or more away from verticalalignment, the doors 237 can close to prevent used needles 104 fromescaping the repository 235. In use, the repository 235 can bevertically oriented relative to the rotational axis to open the door andthe used needle 104 can be dropped in the repository 235 through theopen door 237. The surgeon can then rotate the forearm out of verticalalignment to close the door 237 and grasp a new needle from the suturepacket. The process can be repeated after the needle is used.

Because the suture packets and the sharps container are in closeproximity, the surgeon's movement of releasing a used needle 104 andpicking up a new needle is simple and short. Thus, this configurationhas micro-ergonomic benefits over other suture packet and sharpscontainer methods. As discussed above, the sharps container can be anelastic foam or other material into which used needles 104 are insertedwith the sharp points directed towards a structural layer which blocksthe needle from further movement and protects the surgeon's forearm fromthe used needle. It has also been found that mounting the used needle104 on the dorsum on the forearm can also resist injury to the surgeonfrom the exposed suture ends of the needles. The dorsum of the forearmcan rotate with the hand. However, the forearm is not easily moved intoa position where the dorsum of the forearm faces the body. The forearmis inherently configured with the volar and palmar surfaces facing thebody while the dorsum faces away from the body. This human anatomylimitation provides another safety feature for the inventive forearmmounted platform with sharps container.

With reference to FIGS. 68-71 in an embodiment, the platform apparatusmay include a platform 187 on the dorsum of the forearm onto which asharps container is mounted and suture packet holders 183 mounted on asurface or platform 189 of the apparatus on the volar side of theforearm 143. In this configuration, the surgeon can supinate thenon-dominant assisting limb to rotate the suture packet mounted on thevolar side into any desired orientation before grasping a new armedneedle. As discussed, the human anatomy allows for a wider range ofnatural movement when the volar side of the forearm 143 is facing thebody. Thus, the surgeon can more easily and precisely move the needle tothe desired position before grasping the new needle with the needleholder. The needles are securely attached to the suture packs 101 andrequire a physical force to be removed. Gravity will not cause theneedles to come loose from the suture packs 101 and the placement of thesuture packs 101 below the forearm 143 will not cause new armed needlesto be accidentally released. In contrast, it may not be desirable tomount the tool holders and sharps container on the volar side of thelimb.

With the used sharps container on a dorsal side and suture packs 101 onthe volar side, the movement and micro-ergonomics are slightly differentbecause the surgeon will rotate the forearm 143 after the used needle isplaced in the sharps container and while the new armed needle is beinggrasped. However, because the suture packet 101 and sharps container arestill in close proximity, for example within less than 7 inches, themovement of the surgeon is still very efficient. This configuration alsohas the benefit of a safe used needle 104 position and a more adjustablesuture packet 101 position.

The described process used with a medical apparatus on a forearm of auser can be illustrated with reference to flow chart shown in FIG. 90. Amedical apparatus can have a platform on a dorsal side of the forearmand a volar platform on the volar side of the forearm. A used needlerepository can be attached to the dorsal platform on the dorsal side ofthe medical apparatus and a suture pack holder can be attached to thevolar side of the medical apparatus 209. A suture pack can be placed inthe suture pack holder and the medical apparatus can be worn on a firstarm of a user who can be surgeon, which can be the non-dominant arm 211.The user can move the first arm to adjust the position of the suturepack and the user can grasp a suture needle with a needle driver held bythe second arm of the user which can be the dominant arm 213. The usercan then remove the suture needle from the suture pack and use theneedle to install a suture on a patient 214. Once the suture isinstalled and possibly knotted, the user can move the used needle lessthan one foot from the suture insertion point on the patient and placethe used needle in the sharps container by the surgeon only 215. Thesurgeon can determine if additional sutures are needed 217. If moresutures are needed, the steps 213, 214 and 215 can be repeated until allsutures have been installed on the patient. Once no more sutures areneeded this process is done 219. As discussed, the benefit of thisprocess is that only the surgeon handles the sutures and needles and themovement of the needle can be, for example, within one foot from thesuture insertion point which can improve efficiency and prevent injuryfrom sharps.

The sutures and needles can remain within the near surgical field duringthe installation of the sutures.

In yet another embodiment, the suture packet holder (with a suturepacket) and a sharps container can be mounted on a surgical tool on thesame plane, facing the same direction, or on opposite planes. The suturepacket holder and the sharps container can be held by the surgeon'snon-dominant hand. In the illustrated examples shown in FIGS. 81 and 83the suture packet 101 and the sharps container 191 can be mounted onopposite sides of a surgical tool 201 such as forceps. When the suturepacket holder 183 and the sharps container 191 are mounted opposite eachother, the surgeon can rotate the suture packet 101 toward the needledriver so a new armed needle can be grasped. When the suture has beeninstalled, surgeon can rotate the tool between about 90-270 degrees sothe sharps container 191 faces the used needle and the surgeon candeposit the used needle in the sharps container 191. The surgical toolcan be rotated between about 90-270 degrees back to its originalposition so a new armed needle can be grasped and the process can berepeated. In other embodiments, the suture packets and sharps containercan also all be on same plane, facing the same direction with the unusedand used needles side by side.

An embodiment of this process can be illustrated with reference to theflow chart shown in FIG. 91. A medical apparatus such as forceps canhave a used needle repository on a first side of a proximal end portionand a suture pack holder on an opposite side can be provided to a userwho can be surgeon 221. A suture pack can be placed in the suture packholder and the medical apparatus can be held with a first hand of theuser 223. The user can adjust the position of the suture pack bymovement of the first hand and the user can grasp a needle with a needledriver held by the second hand of the user 225. The user can then removea needle from the suture pack and used the needle to install a suture ona patient 227. Once the suture has been installed, the user can rotatethe medical apparatus so that the needle repository faces the secondhand and the used needle moves less than a foot to place the needle inthe used needle repository which can be a sharps container by thesurgeon only 229. If more sutures are needed, the steps 225, 227 and 228can be repeated until all sutures have been installed on the patient.When no more sutures are needed this process is done 233. Again, thisprocess can be performed by only the surgeon and the needles may moveless than one foot from the incision which can improve efficiency andprevent injury from sharps.

In other embodiments, various types of sharps containers can be used tohold used needles. For example with reference to FIG. 150, the sharpscontainer 255 can have a door 237 that is coupled to a lever 243. Whenthe lever 243 is actuated, the door 237 can open to allow a used needleto be inserted into the sharps container 255. When the lever 237 isreleased, the door 237 can close to prevent the used needles fromescaping. In an illustrated embodiment, the user can simultaneously holdthe forceps 201 and actuate the lever 243 to open/close the door 237 tothe sharps container 255. For example, the user can hold and actuate theforceps 201 between the thumb and long finger. The index finger canindependently contact and actuate the lever 243 to open the door 237.The index finger can also allow the user to apply additional downwardforce to the forceps 201 if necessary.

With reference to FIGS. 77 and 78, in the illustrated embodiment, thesuture pack 101 and sharps container 191 are coupled to each other alonga top side and two vertical sides to form a needle receptacle and suturepack assembly 205. The bottom edge can be open so that the structureforms a tool attachment pocket 204. The inner sides of the suture packand sharps container can be coated or attached to an adhesive layer 203that is covered with a release paper 202 prior to installation on atool. The user can squeeze the two vertical sides of the suture pack 101and sharps container assembly as shown in FIG. 77 to open the pocketshown in FIG. 78. The user can then remove the release paper 202 toexpose the adhesive 203 as shown in FIG. 79. A tool 201 such as aproximal end of forceps can be inserted into the pocket 204 against theadhesive surfaces 203 as shown in FIG. 80. The suture pack 101 andsharps container assembly 191 can be pressed together to secure thedevice to the end of the tool 201 as shown in FIG. 81. Because theinventive structure is being attached to a surgical instrument 201, itcan be important to use lightweight materials so that the feel andbalance of the tool is not significantly reduced when the system isused. In many embodiments, the weight of the structure is less than0.100 lbs or 45 grams.

With reference to FIGS. 82-84 various view of a needle receptacle andsuture pack assembly 204 mounted on a surgical tool 201 are illustrated.FIG. 82 illustrates a front view of the needle receptacle and suturepack assembly 205 with the suture holder 183 with a plurality of suturepacks 101 holding suture needles 103 is illustrated. The suture packs101 can be held to the suture holder 183 with tabs 181. With referenceto FIG. 83, a side view of the needle receptacle and suture packassembly 205 is illustrated with the suture packs 101 on a front sideand the used needle receptacle 191 on the opposite side. With referenceto FIG. 84, a back view of the needle receptacle and suture packassembly 205 with used needles 104 placed in the needle receptacle 191.

In an alternative embodiment, the back surfaces of the suture packetscan be attached to a foam needle repository and the opposite side of theneedle repository can be attached to the tool. In yet another embodimentof a needle receptacle and suture pack assembly 205 as shown in FIGS.85-87, the tool 201 can be attached to one or between two foam needlerepositories 191 that are sandwiched between two suture pack holders183. In this embodiment, the used needles 104 are inserted into theexposed sides of the foam needle repository 191. This provides a muchdeeper used needle 104 insertion because the foam extends across theentire width of the structure rather than the thickness. In theillustrated embodiment, the needle areas can be marked with a sequenceof numbers so that the used needle 104 count can be easily performed.FIG. 85 illustrates a front view of the needle receptacle and suturepack assembly 205 facing one of the suture pack holders 183. FIG. 86illustrates a side view of the needle receptacle and suture packassembly 205 facing one of the foam needle repositories 191 and FIG. 87illustrates a back view facing the second suture pack holder 183.

With reference to FIGS. 72-76, in other embodiments, a platform 145 withsuture packet holders 183 that can include tabs 181 for holding suturepackets 101 and a sharps container 191 can be mounted on a mechanicalarm at a fixed or movable location in the surgical field. For example,the platform 145 can be a separate structure mounted to an arm having anadjustable joint 193 as shown in FIG. 73 or a flexible arm 195 that canbe moved to any desired position as shown in FIG. 74. The base of thearms 193, 195 can be clamped to a fixed surface 197 such as a table.

In other embodiments a solid platform is secured to the surgical drapeon the fringe of the surgical incision. In an embodiment the device ismounted opposite the surgeon if the surgeon has no assistance or on theadjacent side to the surgeon's dominant hand. In an embodimentillustrated in FIGS. 75 and 76, the platform 145 with suture packetholders holding suture packets 101 and a sharps container can be mountedon an “A” frame structure 199 that allows the angle of the platform 145surface to be adjusted. For example, the platform 145 can mount thesuture packets 101 and suture repository 191 at an angle to the surfaceof about 0-50 degrees that most easily facilitates the grasping of thenew armed needles and used needle deposition motions. The platformstructure 199 can be attached to the surgical drape with staples ortape. A platform 145 with the suture packet(s) 101 and sharps container191 adjacent to the needle holder securely mounted to the within thesurgical field will facilitate the improved and more efficient surgicalworkflow. In this embodiment as illustrated in FIG. 72, the proximity ofthe suture packet holders holding suture packets 101 and a sharpscontainer 191 can be within about 4 inches.

A common feature among the inventive devices described above is thatthey combine armed and/or unarmed needle and/or suture pack(s) with aused needle retention device on the same structure. The armed and/orunarmed needle and/or suture pack(s) with a used needle retention devicecan be fixed to the structure permanently and/or in frangibleassociation. This configuration allows for improved micro-ergonomics.The surgeon can hold a needle driver in one hand and another tool suchas forceps in the second hand. The surgeon does not have to let go ofthe needle driver or the forceps when needles are removed from thesuture packs or when the used needles are placed in the used needleretention device. Since the surgeon does not have to remove the fingersfrom the instruments, the procedures can be a more efficient and safersince there is much less likelihood of accidentally dropping aninstrument.

The use of the forearm for needles and used retained needles can provideimproved efficiency, safety, and better micro-ergonomics. Using such asystem, the surgeon always knows where used needles are located. It isalso is very difficult to accidentally jab the surgeon's body with theused needles unless the surgeon crosses forearms to appose the dorsum ofnon-dominant forearm to another part of your body. If used needles areon the surgical field it is much easier for the surgeon's hand toaccidentally be placed on them. Having the new and used needles on thein close proximity allows for apposition. The installation of sutures ina patient is done with a circular motion by the surgeon. The surgeon canmore easily, drop a used needle off in the sharps container and grab thenext new needle.

As illustrated in the top view of an embodiment of the inventiveplatform shown in FIG. 49, the system can include tool holders 177,suture pack holders 183 and a sharps container 191. In an embodiment,one of the tools stored in the tool holder 177 can be a bulb irrigator,which can be a hollow container that stores saline for irrigation of thesurgical wound. The surgeon can point the nozzle of the bulb irrigatorat the wound and squeeze the bulb portion to control the flow anddirection of the saline. By storing the bulb irrigator on the platform145, the surgeon can access this tool at any time. The scrub tech who isobserving the surgery can assess, and thereby anticipate that the nextstep might be: bone wax or gelfoam application (as required duringcertain procedures, such as lumbar decompression) or cottonoid in thatstepwise function. For example, the surgeon can reach for the bulbirrigator, perform the irrigation and upon placing it back on theplatform 145 the scrub tech can know to be ready with the next step.Since the surgeon is handling the bulb irrigator, the surgeon will knowhow much saline is left in the bulb. The surgeon can feel and see thequantity of saline in the bulb irrigator and ask for more saline when arefill is needed. Alternatively, the scrub tech can spend more timewatching the surgeon and less time passing objects to the surgeon. Bywatching the surgeon handle the bulb irrigator, the scrub tech can seewhen the fluid level is running low and anticipate the need for moresaline. Because the actions of the surgeon and scrub tech are moreindependent, all parties can be more focused on the surgery andcommunications can be improved. These same benefits would apply to theneedle handling processes of the inventive system described above.

In some of the illustrated embodiments, the used needles are insertedinto a foam sharps container coupled to a planar mounting surface suchas a platform with the lengths of the needle approximately perpendicularto the mounting surface as shown in FIGS. 102 and 103. In otherembodiments with reference to FIG. 104, the sharps container 257 can beoriented so that the used needles 104 are inserted into sides of thesharps container 257 so that the needles 104 are more parallel to themounting surface. In an embodiment, sides of a container 257 structurecan surround the foam, except for the used needle insertion side of thecontainer 257. The container 257 can be made of a clear material andmarked with numberings 259 for needle counting. The container 257 canprevent the sharp tips of the needle 104 from exiting the sharpscontainer 257 and the increased insertion depth prevents the needlesfrom escaping. Both of these features increase the safety of the device.

In other embodiments, suture packs 101 can be placed on the uppersurface of the sharps container 257. With reference to FIG. 105 a sideview of the sharps container 257 with suture packs 101 mounted on afront surface are illustrated. FIG. 106 illustrates a front view of thesuture packs 101 holding sutures 103 mounted on the sharps container257.

In an embodiment with reference to FIG. 107, multiple layers of needlerepositories 257 can be stacked together with the inner repository 257attached to a mounting surface which can be on a protective platform ora tool. The opposite exposed side of the sharps container can be used tomount one or more stacked suture packets 101 that can be held togetherwith an adhesive. Needles can be removed from the outermost suturepacket and the used needle 104 can be inserted into the side of thesharps container 257. The used needles 104 can be inserted into the sideof the sharps container 257 into a foam material 263 that can be markedwith numberings 259 for needle counting. When the suture packet 101 isout of needles it can be removed to expose an underlying suture packet101. Because the suture packets 101 and sharps container 257 are in veryclose proximity, the micro-ergonomics of the surgical procedure areimproved.

In an embodiment with reference to FIGS. 108-110, the sharps container257 can include a material that the used needles 104 are inserted into asingle piece needle holding material through multiple surfaces. In theillustrated example, a foam material 263 can be placed within acontainer structure 257 which includes a plurality of elongated openings364 and numerical markings 258. The used needles 104 can be insertedinto an exposed top surface as well as a side surface. The used needles104 inserted through the top surface can be oriented at a shallowdiagonal angle relative to the mounting surface and the used needles 104inserted through the side surface can be more parallel to the mountingsurface. In another embodiment with reference to FIGS. 111-113, dividers261 can be placed in the container structure 257 which separate theadjacent needle holding material pieces. In this embodiment, each usedneedle 104 is inserted into a specific used needle passageway which canhelp to improve needle count accuracy.

With reference to FIGS. 114-116 in other embodiments, the sharpscontainer 257 can be configured with access only through the sidesurfaces with multiple layers so that the used needles 104 are placed inmultiple planes and mounted between one or more stacked suture packets101 and a mounting surface. The assembly components can be held togetherwith an adhesive and the assembly can be attached to the mountingsurface with an adhesive. The mounting surface can be a tool surface ora platform surface. The new needles 103 can be removed from theoutermost suture packet 101. When all needles 103 are removed from theoutermost suture packet 101, the user can peel away the depleted suturepacket 101 to exposed a full underlying suture packet 101.

In other embodiments, the suture packet 101 and used needle receptacle257 can be configured in a diagonal manner like layered shingles. In theillustrated example shown in FIGS. 117-119, a plurality of suturepackets 101 are stacked on a left side of the assembly 205. Needles 103are removed, used and then placed in the needle receptacle 257. Thesuture packets 101 can be held in place with an adhesive and when theneedles 103 are depleted, the outermost suture packet 101 can be peeledaway and discarded to expose the next suture packet 101. The used needlereceptacle 257 can have a single piece foam structure or multiple foam263 pieces which can have a plurality of diagonally oriented dividers261 separating the multiple foam 263 pieces. The dividers 261 can directthe needles 104 in a diagonal direction relative to the lower mountingsurface. This diagonal configuration increases the insertion depth andallows the user to view the insertion points on an upper surface of theassembly 205. The exposed surfaces of the sharps container 257 can benumbered 259. In addition to the upper surface insertion points, theused needles 104 can also be inserted into one or more layers through aside surface. In an alternative embodiment shown in FIGS. 120-122, thedividers 261 between the different layers of the sharps container 257can be curved so that they can be similar to the curvature of the usedneedles 104. This can improve the used needle insertion since the usedneedles 104 can follow the curvature of the dividers 257 and are lesslikely to collide with the dividers 257.

With reference to FIGS. 123-125, as discussed potential safety problemwith used needles 104 is their ability to transmit viruses when a usedneedle 104 accidentally breaks the skin on an operating room surgicalmember. If the used needle 104 is cleaned and/or disinfected the usedneedles 104 are much less likely to spread viruses. In an embodimentwith reference to FIGS. 123-140, the used needle receptacle 257 caninclude a disinfectant fluid container 264 encapsulated within a portionof the sharps container 255. The disinfectant fluid can be a liquid,gel, powder or any other suitable antimicrobial material 266. Theportion of the sharps container 255 used to contain the antimicrobialmaterial 266 can be a clear plastic and other transparent material. Anelastic material 251 can be attached to the portion of the disinfectantfluid container 264 that can seal the antimicrobial material 266 in thedisinfectant fluid container 264 portion of the sharps container 255.The elastic material 251 can be foam, rubber, plastic or any othersuitable material that can be punctured by the used needles 104.

When a needle 104 is placed in the sharps container 255, the surgeon candrive the sharp tip of the needle 104 through the elastic material 251.The needle 104 can be covered with body fluids and may be contaminatedwith bacteria and/or viruses. The used needle 104 tip can pass throughthe elastic material 251 and into the antimicrobial material 266 in thecontainer 264 portion. Since the container material can be transparent,the user to see the used needle 104 tips in the antimicrobial material266. The elastic material 251 may create a tight seal around theperimeter of the used needle 104 which can prevent the antimicrobialliquid 266 from escaping from the fluid container 264 portion of theneedle receptacle 257.

The portions of the used needles 104 that are inserted into theantimicrobial material 266 are cleaned and disinfected. Thus, these usedneedles 104 are properly treated by the act of inserting the usedneedles 104 into the receptacle 257. These disinfected treated needles104 pose much less of a threat of transferring an infection or diseasein the event of subsequent human contact. If the used needle 104 isaccidentally removed from the used needle receptacle 257, the surface ofthe needle 104 will slide against the elastic material 251 which willfurther clean the needle 104 as it is removed from the needle receptacle257 further reducing the risk of spreading an infection or diseasecompared to untreated used needles 104.

After sutures are used to close a patient, the surgical team mustperform a needle count to insure that none of the used needles 104 arein the patient. In an embodiment the used needle receptacle 257 can havea sequential series of number markings 259. The numeric markings 259 canbe on the elastic material 251 or on any other suitable portions of thereceptacle 257. The surgeon can place the used needles 104 in thenumbered spaces in the marked sequence. During the needle count, thecounter can easily perform the count by looking at the last numberedarea of each receptacle 257 having an inserted used needle 104.

The used needles 104 should be placed as far as possible into the usedneedle receptacle 257. However, the proximal end will normally beexposed after the used needle 104 is inserted into the receptacle 257.These proximal ends are not as sharp as the distal ends but can still besharp enough to cause injury to people. With reference to FIGS. 126-128,In order to reduce the risk of injury, the used needle receptacle caninclude barriers 261 that are adjacent to the can extend outward fromthe elastic material 251. The barriers 261 can create channels that cansurround the proximal ends of the needles 104 inserted into thereceptacle 257. The channels can be open on two sides and the widths ofthe channels can be wide enough for the needle driver to easily insertthe used needle 104 through the elastic material 251. These channels canalso prevent injury to the surgical staff. Even if the used needlereceptacle 257 is pressed against a body, walls of the channels canprevent the exposed proximal ends of the needles 104 from causinginjury. If the proximal end of the used needle 104 extends past theouter edge of the channels, physical contact with a proximal end willtend to safely push the needle 104 deeper into the elastic material 251and move the proximal end into channels.

The suture needles 104 are generally curved in shape. Thus, it may beeasier to insert the used needles 104 into the used needle receptacle ifthe channels are also curved or angled as shown in FIGS. 129-136. Inthese configurations, the surgeon can insert the used needles 104 withthe convex curvature side of the needle facing the concave or inwardcurvature of the channel walls. When the used needle 104 is fullyinserted, the ends of the used needle 104 can be aligned rather thanbeing offset. Different users may prefer different channel angles orcurvatures. For example, a right handed surgeon may prefer channels thathave top ends that are angled to the left as shown in FIGS. 129 and 130or curved to the left as shown in FIGS. 133 and 134. In contrast, lefthanded surgeons may prefer channels that have top ends that are angledto the right as shown in FIGS. 131 and 132 or curved to the right asshown in FIGS. 135 and 136.

In some embodiments, multiple used needle sharps containers can be usedtogether to hold a greater number of used needles 104. In an embodimentshown in FIGS. 137 and 138, the used needle sharps containers 255 can bearranged in an overlapping configuration with the channel portions ofeach of the sharps containers 255 exposed. The sequential numbering 259on the channels can be clearly visible when the surgeon places the usedneedles 104 into the sharps containers 255. The tip of the needle drivercan fit within the channels so the proximal ends of the used needles 104will be completely within the protective channels. It is also possibleto place one or more suture packets 101 on the uncovered surface of thefirst sharps container 255 as described previously. In other embodimentsas shown in FIGS. 139-140, the sharps containers 255 can be arranged ina vertical manner with only the used needle input ends exposed. Thenumber markings 259 can be seen on the exposed elastic layer 251 by thesurgeon.

In some embodiments of the present invention, locking mechanisms 265 canbe used with the sharps containers 255 as shown in FIGS. 153 and 154.The locking mechanisms 265 can allow the needles 104 to be inserted butmay prevent the used needles 104 from being removed. In an embodiment, alocking mechanism 265 can be located within each of the channels of asharps container 255. The walls of the channel can taper to guide thetip of the needle 104 to the locking mechanism 265 and the lockingmechanism 265 can include one or more hinged arms 268 that can beoverlapping on opposite sides of the channel. With reference to FIG.154, when the needle 104 is pressed into the locking mechanism 265, thearms 268 can deflect downward so that the arms 268 are pressed againstopposite sides of the used needle 104. The arms 268 will then clamp downon the needle 104 to prevent it from being removed from the channel thuslooking the used needle 104 into the sharps container 255.

In other embodiments with reference to FIGS. 155 and 156, the lockingmechanism 265 can include multiple cams 275. The used needles 104 can bepressed through multiple cams 275 which are mounted on opposite sides ofthe channel 277. The cams 275 can rotate downward to allow the needles104 to enter the sharps container 255. If an upward force is applied tothe needles 104, the cams 275 will rotate upward and clamp the oppositesides of the needle 104 at each cam 275 to prevent the needles 104 frombeing removed. In other embodiments, various other locking mechanismscan be used to prevent the used needles 104 from being removed from thesharps container.

In an embodiment, the sharps containers 255 can have indicators thatindicate that the needle is properly placed in the channel 277 of thesharps container 255. In the illustrated example, foam indicator blocks279 can be mounted just below each of the cams 275. The friction forceof the foam 279 against the sides of the channel 277 can hold the blocks279 in place. After the needle 104 tip passes through the cams 275, itcontact the upper surface of the foam indicator block 279 and thedownward force of the needle 104 can move the foam block 279 to a lowerportion of the channel 277. Eventually, the foam block 279 may contactthe bottom of the channel 277 and the used needle 104 can be furtherinserted into the foam block 279 without any additional movement of theblock 279. In an embodiment the foam block 279 can be concealed in theupper position and visible in the lower position so that users caneasily see if the channel 277 of the sharps container 255 is filled witha used needle 104. FIG. 155 illustrates the sharps container 255 withthe foam blocks 279 in the upper positions covered with numericalmarkings 259.

In other embodiments, other types of locking mechanisms and indicatorscan be used with the sharps container. In an embodiment illustrated inFIGS. 151-152, the used needles 104 can be electrically conductive andmagnetic. FIG. 151 illustrates sharps container 255 with the electricalcircuitry and locking mechanism 265 visible. FIG. 152 illustrates thesharps container 255 with the electrical circuitry and locking mechanism265 covered with numerical markings 259. The channels 277 can have anupper electric circuit for a light indicator system. The upper lightindicator circuit is normally open with the light 267 off. The needle104 is placed into the locking mechanism 265, which is electricallyconnected to light 267 and a positive or negative lead of the battery269. When the needle 104 is pressed through the locking mechanism 265 toa lower conductor 271 the electrical contact of the used needle 104closes the circuit illuminating the channel light 267. Because theneedle 104 is locked in place, the light 267 will remain illuminated.

In the illustrated embodiment, the lower circuit turns on theelectromagnet 273 when the tip of the needle 104 is adjacent to theelectromagnet. In this embodiment, the lower circuit is completed whenthe needle 104 which is in contact with the middle conductor 270 alsotouches the lower conductor 271. This electrical connection between themiddle conductor 270 and lower conductor 271 completes the circuit andcauses the electromagnet to energize pulling the needle against theelectromagnet 273. It would be easy to slide the needle 104 against acharge electromagnet 273 so it should be energized once the needle 104is in the proper position. In this embodiment, the electromagnet 273provides a locking mechanism that prevents the needle 104 from beingremoved from the sharps container 255. The electromagnetic 273 lockingmechanism can be used alone or in combination with other lockingmechanisms.

In other embodiments, the sharps container 255 can have battery 269 andcontrol electronics that senses presence of needle 104 and keeps ongoingcount and has indicator lights 267 or display that lets operator knowthe relative or absolute absence of needle same device can containtransmitter to communicate wirelessly with other devices and electronicsincluding via Bluetooth or low frequency low energy transmitterincluding tablets, computers, mobile phones etc. Sensors may senseimpedance changes, weight, electrical resistance, volumetric, etc. Thesensor information can be used to indicate the number of used needles104 in the sharps container for the purpose of providing an accurateused needle 104 count. The electromagnet 273 can work through a plasticlayer. Therefore in some embodiments, the used needles 104 are not indirect contact with the electromagnets 273. When the used needles 104need to be removed from the sharps container 255, the electromagnets 273can be turned off. In an embodiment, electromagnet 273 can be used tosecure the sharps container 255 to a magnetic forearm platform.

As discussed above, the needle receptacle and suture packet assembly canbe placed on the end of a surgical tool. The prior example illustratedsuture packets on the exposed sides and a used needle receptacle alongthe edge of the assembly. In other embodiments as illustrated in FIG.142, it is also possible to have the used needle receptacles on theexposed sides and the suture packets placed on the edge of the assemblybetween the used needle receptacles. In the illustrated example, theproximal ends of the new needles 103 in the suture packets 101 can beexposed and extend away from the edges of the used needle receptacles257. In an embodiment with reference to FIG. 141, the portion of thesuture packet 101 adjacent to the proximal ends of the new needles 103can be bent or removed to expose the proximal ends along the dashedline. With reference to FIGS. 144 and 145, the suture packet 101 and theproximal end of a surgical tool 201 can then be positioned against thebacks of the used needle receptacles 257 to form a used needlereceptacle and suture pack assembly 258. The used needle receptacles 257can be secured to the proximal end of the tool 201 with an adhesive orany other suitable coupling mechanism.

The surgeon can grasp a proximal end of a new needle 103 from the usedneedle receptacle and suture pack assembly 258 and install the suture.The surgeon can then insert the used needle 104 in the next sequentialspace in the used needle receptacle 257. The surgeon can then graspanother new needle 103 and repeat the process. This process is moreefficient because the surgeon does not need to reply upon a scrub techto handle needles and needle drivers. This process is also safer becausethere is limited, or no coordinated handling of needles between thesurgeon and the scrub tech reducing the risk of mishandling.

Embodiments of the present invention are directed towards sharpscontainers that can provide a lightweight structure that securely storebetween about 2-20 used needles in the immediate proximity of thesurgeon. The sharps container can be less than approximately 4 inches inheight or length, 4 inches in width and 3 inches in thickness and can beheld on a surgical tool, a platform supported by the surgeon or anyother movable structure controlled by the surgeon. The inventive sharpscontainer can have an internal volume for storing the used sharps and inan embodiment, the container can have a movable door that can be open toinsert the used sharps and closed to prevent the used sharps fromescaping. The shape of the sharps container can be cylindrical, boxshaped or any other suitable shape that has an internal volume that islarge enough to store about 2-20 used needles 104. Because the usedsharps container can be on the end of a surgical tool, the weight of theused sharps container is preferably less than 0.100 lbs. or 45 grams.

In many embodiments, the surgeon takes responsibility for securing theneedle or group of needles prior to passing to the assistant. The sutureneedles can be curved solid needles that pass through tissue. Thus,these needles pass through very small holes in the tissue and theneedles cannot have adaptions on the back end of the needle to slideover the needle to safely secure the sharp used needle tip in at leastsome embodiments.

In an embodiment, the present invention provides a means for safelysecuring the used surgical needle in the surgical field with theshortest route for the contaminated needle from tissue to a used sharpscontainer. The process is substantially shorter because the needle onlytravels a short distance that is normally less than one foot, forexample within the near surgical field.

The design and use of the inventive sharps container as described andillustrated has physical properties that do not interfere with thesurgeon's workflow in closing patient wounds. Work in relation toembodiments suggests that securing used needles to a sharps containerpositioned on the instrument or on the surgeon's forearm or handactually expedites the procedure, in addition to making the proceduresafer. There can be no shorter physical path for the needle to a sharpscontainer that is attached to hand/forearm or back of surgical tools onthe surgeon's anatomy. Thus, the inventive system also minimizes thedistance that the used needles must travel and eliminates unnecessarymovement of the used needles, which increases the efficiency and reducesthe required time. The inventive process has the benefits of onlyrequiring the surgeon to perform the entire task, which minimizes thehandling of a used sharp needle which increases the safety of theinventive system.

FIG. 146 is a block diagram of an apparatus 308 comprising an integratedsuture packet and needle receptacle, in accordance with embodiments. Inan embodiment of the present invention, a plurality of new needles 103can be packaged with a sharps container or needle receptacle 257 as asingle integrated unit 308 that can share the same housing 309. Theneedle receptacle may comprise any sharps container or needle receptacleas described herein (e.g., used needle receptacle 191, sharps container257, needle trap 331, etc.), configured to secure a plurality ofdispensed suture needles 104. The integrated suture packet and sharpscontainer can include a predetermined number of new needles and a sharpscontainer that includes sufficient room for at least the predeterminednumber of used needles. For example, in an embodiment the integratedsuture packet and sharps container can contain five new needles in thesuture packet within or mounted on a first portion of the housing withan optimized sharps container for the used needle that can acceptbetween about five to seven used needles. In other embodiments, theintegrated unit can have any other number of needles, for example, 10 or20 or more. However, the integrated sharps container is preferably ableto hold an equal number or more used needles than new needles.

In some embodiments, the integrated suture packet and sharps container308 share a housing 309, with the new armed needles 103 accessible froma first side 303 of the housing, and the sharps container 257 disposedon a second side 304 of the housing. For example, in a first embodimentthe surgeon may use a needle driver to grasp an armed needle from afirst side of the housing. The surgeon can use the suture and place theused needle in the sharps container through a door in a second side,such as the top surface, of the housing. The user can open the door toinsert the used needle and then close the door to prevent the usedneedle from escaping.

In other embodiments, a protective door can be closed to shield thearmed needles. This can be useful if the integrated suture packet andsharps containers are placed in storage to protect the needles. Indifferent embodiments, the protective doors can be opened in variousdifferent ways. In an illustrated embodiment, the door may slide side toside or up/down so that the surgeon can easily open the door to accessnew armed needles. In other embodiments, multiple doors can open toallow access to the armed needles. In some embodiments, the protectivedoor can be manually operated. In other embodiments, an actuator can beused to control the position of the protective door. The housing canalso have an outer surface which can be used for labels or markings toprovide needle and/or housing information.

Such an integrated configuration of a suture pack and a needlereceptacle can provide improved safety and efficiency benefits describedherein. Sharps containers can have many different varieties including:foam with demarcations that allow for multiple needles, foam encased inan outer shell such that needles cannot pass out the sides of the shell,foam encased in the outer shell having an aperture for introducing theused needles, the aperture is more narrow that the width of the housingsuch that with the bend of the needle, the housing will capture theneedle tip. The foam represents a reservoir type vehicle for capturingneedles in which the surgeon has flexibility on the orientation andlocation to place the used needles.

Another sharps container embodiment includes specific holes into whichthe needles are place by the surgeon. The used needles can go in but themechanism captures the needle and does not allow removal of the usedneedles 104. Such mechanisms can include a cone with tapered tip andmalleable leaves that bend to allow needle passage but preventremoval-similar in shape to lobster trap. Another mechanism is a cam orseveral cams with ratchet. As a used needle is introduced the camsrotate and compress the tip of the needle. Rotation of the cams can alsoexpose side of the cam with a color change indicating the presence ofthe needle. There many potential mechanisms for capturing individualneedles at fixed location.

FIGS. 147A-149 illustrates exemplary embodiments of a sharps containerin the form of a cartridge. The cartridge can be attached to theinstruments that are typically used in the non-dominant hand such as thesurgical pickups, Adsons, Bonneys, etc. The cartridge can be designed tobe secure to the pickups and can include a mounting mechanism that canallow the cartridge to be easily attached and detached from the tool orstructure. In addition to the sharps container, the cartridge can alsoinclude one or more needle packages and broad labeling on an outersurface of the housing that can be easily visible to the surgeon. FIG.150 illustrates an embodiment of a sharps container 255 coupled to asurgical instrument 201.

In an embodiment, the cartridge can include an attachment mechanism(s).The attachment mechanism can be used to couple the cartridge to anotherobject such as a tool or a platform. In an embodiment the attachmentmechanism can be a slot or slots or holes in the cartridge into whichthe non-surgical end of the pickup attaches, or can incorporate andadaption of the surgical pickup. In other embodiments, the attachmentmechanisms can include permanent magnets which can be used to secure thecartridge to the tool. With reference to FIG. 157 in the illustratedexample, the cartridge 281 has two holes 283 which correspond to twoelongated rods 285 that extend from the proximal end of a forceps tool201. Permanent magnets 287 can also be mounted at the proximal end ofthe forceps tool 201 so that the magnets 287 in the cartridge 281 willbe attracted to magnets 287 in the forceps tool 201 and the magneticattraction will hold the cartridge 281 in place. The cartridge 281 canbe separated with a force greater than the magnetic attraction force isapplied.

In other embodiments, a pure mechanical locking mechanism can be used tosecure the cartridge to another object. In an illustrated example FIGS.158-159, the bottom of the cartridge 281 has two tabs 289 which canengage corresponding recesses 291 in a coupling. When pressed together,the tabs 289 can deflect inward so that the outer surfaces of tabs 289slide against the inner surfaces of the coupling. The tabs 289 can thenengage the slots 291 in the inner surfaces of the coupling to rigidlysecure the cartridge 281 to the top of the forceps tool 201. The usercan squeeze the tabs 289 inward through the slots 291 to disconnect thecartridge 281 from the forceps tool 201.

In different embodiments, the fresh needle side of the cartridge canhave a protective cover or door that moves or slides to expose the armedneedle. The protective cover or door mechanism can be actuated in anydirection, up down or sideways.

The cartridge can have an oval cross section with the fresh needlesrecessed from the face. Once the cover or door is open, the freshneedles are accessible to the surgeon.

The sharps container can be closed cell foam on the contralateral sidethat also is marked and has an aperture on the face. The foam may extendto the full border of the face to facilitate the capture and retentionof the used needles 104. The walls of the cartridge are not penetrableby the needle to protect the needle from coming out of the side of thehousing.

The sharps container can have a magnetic base that can help to preventused sharps from accidental removal and the sharps container can also bea clear transparent structure that can allow the used needles 104 to bemore easily counted. The sharps container can have a dome coverage thatallows used needles 104 to pass through by rotating the needle through asmall aperture so needle can enter the sharps container at any angle.The sharps container may include a magnetic base with covers that lockin place as needle placed in the container. Locking or closing thesharps container lid may expose the next new armed needle(s) or actuateand open the door covering the new needles.

With reference to FIGS. 160-166 in yet another embodiment of the sharpscontainer, a hole 293 is a housing 295 can be covered with a thin layerof elastic foam 263. A larger width volume of the sharps container canbe located under the hole 293. Thus, when a needle 104 is placed intothe foam 263 over the hole 293, the needle 104 will pass through thefoam 263 and the middle portion of the needle 104 may be positionedwithin the hole 293 and the sharp tip can be within the wider volumebelow the hole 293. In an embodiment, this embodiment of the sharpscontainer can include a layer of elastic foam 263 that can be betweenabout 1-10 mm thick covering an underlying hole 293 that can be betweenabout 2-50 mm in diameter or wide. The hole 293 depth can also bebetween about 2-50 mm. The foam material 263 can be bonded to the top ofthe housing 295 and can cover the hole 293 like a drum. Thisconfiguration can have several benefits. The needle 104 tip can moreeasily pass through the foam 263 layer with less force than a thickerfoam layer. However, the thinner foam 263 layer still provides enoughsliding resistance to prevent the used needles 104 from becomingdislodged by gravity. The proximal aspect of the needle 104 will stillremain above the foam layer 263.

Forces on the proximal aspect of the needle 104 do not need to be verylarge to cause the needle 104 to be further advanced through the foam263 layer or rotate the needle 104 within the foam 263. The foam 263 canalso allow for low force angulatory displacement of the needle 104relative to the plane of the foam 263. Thus, if a side force is appliedto the exposed proximal portion the needle 104 will simply bend relativeto the plane of the foam 263. Under the foam 263, there is a sufficientvolume for the distal tip of the needle 104 to move around within thesharps container housing 295. Because the foam 263 can allow formovement of the needle 104 even after it has been inserted, there is areduced risk of injury to human skin by the proximal aspect of theneedle 104. As discussed, a downward force on the needle 104 will causeit to be pushed further through the foam 263 into the sharps containerand a horizontal force will cause the needle 104 to rotate about thefoam 263 entrance point.

In different embodiments, the hole 293 size and the foam 263 thicknesscan both be variable. The size and physical properties of the foam 263and hole 293 can be selected to provide optimized functionality basedupon the types of needles 104 being used. Smaller needles 104 arelighter weight can use thinner lower density foam 263 over a smallerhole 293 while longer needles 104 may need thicker higher density foam263 over a larger hole 293. The shape of the underlying volume of thecontainer will need to be optimized to allow for maximal needle 104 tipexcursion.

In an embodiment, the position of the holes 293 can be indicated bycorresponding circular markings 297 on the exposed side of the foam 263so that the user can easily locate the holes 293 under the foam 263layer. The holes 293 can be numerically marked 259 so to help withneedle 104 counts. The hole 293 can be part of a tubular structure thatextends into the housing 295 as shown in FIGS. 160 and 162.Alternatively, the hole 293 can be planar with the wall of the sharpscontainer structure housing 295 as shown in FIGS. 161 and 163.

With reference to FIG. 166, in an embodiment, the sharps container caninclude many holes 293 that are each covered with a foam 263 layer. Eachof the holes can be marked with a circular marking 297 to visuallyindicate the locations of the holes 293. A sequence of numericalmarkings 259 can also be placed within each of the circular markings 297to aid with the needle count. The used needles can be sequentiallyplaced in different circular markings 259 through the foam 263 in theorder of the numerical markings 297 which can simplify the counting ofthe used needles.

In other embodiments with reference to FIGS. 164 and 165, it is possibleto modify the device above the plane of the foam 263 to further limitaccess to the proximal aspect of the needle 104. For example, in anembodiment, sharps container can include protective structures 299 onopposite sides of the needle insertion hole. For example, the protectivestructure 299 can have two trapezoidal openings orthogonal to oneanother. The user can insert the used needle 104 into the trapezoidalopenings, through the foam layer 263 and into the underlying hole 293.It is also possible to have a large number of used needle holes 293 inthe sharps housing 295 that are each similar to the described usedneedle 104 hole structures. Again, the position of the hole 293 can bevisually indicated by the circular marking 297 and the numeric sequenceof the hole 293 can be indicated by the numeric marking 259.

In an embodiment, a modular medical device comprising a forearm-mountedpuncture barrier functions as a platform upon which one or more usedneedle repositories and/or one or more suture packs or suture packcarriers can be mounted. The used needle repositories and the suturepacks/carriers can be coupled to the forearm mounted puncture barrier byany of the coupling mechanisms described above or by any other suitablemethod. The used needle repositories can include various needle trapdevices and the suture pack carriers can include a clip for holding asuture pack to the forearm mounted puncture barrier. The needle trap canbe removable from the forearm mounted puncture barrier and is intendedfor replacement when the device has secured the intended number ofcontaminated needles.

An embodiment of a used needle trap is illustrated in FIG. 168, which isa top view of the needle trap 331 with suture pack holder 351, which canhold suture pack 101, and suture pack 353. In the illustratedembodiment, the needle trap 331 can be a planar device that is comprisedof several zones: 1) an entry zone 333, 2) an entryway or transitionzone 335 and 3) the secure zone 337. The needle trap 331 can include anupper structure 339 and a lower structure 341 that are securely coupledtogether around an outer portion of the needle trap 331. The needle trap331 can have a needle driver slot 343 extending through both the upperstructure 339 and a lower structure 341, the needle driver slotconfigured to provide clearance for the needle driver along the entirelength of the needle translation from entry zone 333 to secure zone 337.The needle trap can further comprise a needle slot 349 that constrainsthe secured needles into a single needle depth array, to minimizeoverall depth profile and facilitate needle counting. The configurationof the needle trap 331 can be described with reference to an X axis thatextends from left to right and Y axis extends up and down when viewingthe front or top of the needle trap 331 from the perspective of thesurgeon, and a Z axis which defines a depth position.

In an embodiment, the entry zone 333 of the used needle container 331can be a partially circular flat zone or area in the X-Y plane that isan exposed part of the lower structure 341. The surgeon can hold theused needles 104 with a needle driver and place the used needles 104 onan upper surface of the entry zone 333. The contact and/or force of theneedle 104 against the entry zone 333 can cause the curvature of theused needles 104 to be moved into a planar orientation flat against thelanding zone surface X-Y plane with the convex mid-portion of the curvedneedle 104 facing or pointing towards the transitional zone 335.

The entry zone 333 can be wider (y-axis) relative to needle slot 349 andthe perimeter around the entry zone 333 can have a contrasting color toaid visual recognition. The upper surface of the entry zone 333 surfacecan include a low friction material. Graphic guides on the entry zone333 surface can help to reinforce needle 104 rotational orientation. Theneedle driver slot 343 can extend into the entry zone 333 and the widthof the needle driver slot 343 can be greater or oversized in the entryzone to facilitate fast location of the entrance to the needle trap withthe needle driver. The needle driver slot can taper as it extendsthrough the transition zone 335 towards the secure zone 337, to providea self-centering close fit with the tip of the needle driver in thetransition zone 335 and secure zone 337.

The transition zone 335 is disposed between the entry zone 333 and thesecure zone 337. In the transition zone, the compressive side load onthe needles ends may be increased and the depth (z-axis) of the needleslot can narrowed as the secured needles are translated through thetransition zone, constraining the needles to a single needle deep arrayextending longitudinally along the secure zone 337.

The secure zone 337 comprises the region adjacent to the transition zone335, in which full compressive side loading is applied to the needleends to prevent unintentional removal or dislodging of the needles.

The boundary 345 may be concave, wedge or “V” shaped, with the apex ofthe “V” shape pointing towards the secure zone 337 to promote properorientation of the needles 104.

In an embodiment, the transition zone 335 can include a concave, wedgeor “V” shaped boundary on a side of the entry zone 333 in the upperstructure 339 with the apex of the “V” shaped boundary pointing towardsthe secure zone 337 to promote proper orientation of the needles 104.The secured needle 104 in the needle trap 331 can be configured to havethe convex side of the needle 104 facing the secure zone 337 and theconcave side, sharp point and tail of the needle 104 facing towards theentry zone 333. Thus, the needle trap 331 can be configured to have thesharp leading and trailing ends of the needle 104 pointing away from thedirection of motion, thereby reducing the risk of needle-stick injury.The transition zone 335 can have a flared cowling over a portion of thelanding zone and tapered surfaces in both the Y-axis and the Z-axis, toreduce the width and height from the entry zone 337 to a single needleheight and width in the used needle slot 349 as the needle 104 is movedalong the longitudinal X-axis path from the transition zone 335 to thesecure zone 337. The needle driver slot 343 can intersect a portion ofthe needle slot 349, such as a middle portion of the needle slot, andcan be in the midline of the used needle trap 331 in the X-axis suchthat the distal tip of the needle driver can translate the needle 104along the X-axis of the used needle trap 331. Alternatively, the needledriver slot 343 can intersect the needle slot 349 off the midline orasymmetrically, such that the needle driver slot extends along an axissubstantially parallel to, but not overlapping, the X-axis of the usedneedle trap 331. The needles 104 can slide within the needle slot 349deeper into the secure needle zone 337 without excessive resistance orsensitivity as to how the needles 104 are grasped by the needle holder.In an embodiment, the secure zone 337 can prevent used needles 104 frombeing removed from the used needle trap 331.

In a preferred embodiment, the needle 104 is moved into contact with theentry zone 333 of the lower structure 341 by the surgeon manipulatingthe tip of the needle driver in the needle driver slot 343. The needles104 can be pushed against the entry zone 333 and become aligned with theX-Y plane of the used needle trap 331. The needles 104 can then be movedin translation along the longitudinal X-axis of the used needle trap 331from the entry zone 333 into the transition zone 107 where the needles104 slide into the used needle slot 349 with the convex side facing thesecure zone 337 and the sharp tip and tail of the needle 104 facing theentry zone 333. The needle driver can move the used needles 104 into theused needle slot 349 in the secure zone 337 until the needle driver runsinto the end of the needle slot 349 or the last inserted used needle104, or the needle 104 contacts the end stop 363 of the needle slot 349.

In an embodiment, the distal tip of the needle driver holding a needle104 can have an elongated cross section and the width of the needledriver slot 343 can narrow in the secure zone 337 so that the distal tipof the needle driver must be oriented with the longer cross sectiondimension aligned with the needle driver slot 343. This needle driverorientation can also cause the needle 104 properly aligned across thewidth of the secure zone 337 within the needle trap 331. Thus, thenarrowing of the needle driver slot 343 can force the needle driver toproperly orient the needles 104 in the secure zone 337 as the needledriver slides against the sides of the needle driver slot 343 in thesecure zone 337.

FIG. 168 illustrates a top view of an embodiment of a needle trap 331.In different embodiments, the needle trap 331 can have differentdimension depending upon the size of the needles 104 being stored. Thus,a small needle trap 331 used to store smaller needles 104 can havesmaller dimensions than a large needle trap 331 used to store largerneedles. With reference to TABLE 1 below, the ranges of dimensions ofembodiments of a small and a large needle traps 331 of different sizedembodiments are listed. The length can extend along the X-axis, thewidth can extend along the Y-axis and the thickness can extend along theZ-axis. The entry zone 333 can have a circular portion and the “entryzone radius” can be the radius range of the circular portion. The needleslot thickness can be the range of distances between the lower surfaceof the upper structure 339 (not including the protrusions 361) in thesecure zone 337 and the upper surface of the compressible members 347.In other embodiments, the needle traps 331 can have any other dimensionswhich will allow the storage of needles 104. The dimensional ranges intable 1 are in inches.

TABLE 1 Entry zone Needle slot Size Length Width Thickness radiusthickness Small 2.5 to 4.5 0.8 to 2.0 0.1 to 0.5 0.5 to 1.0 0.01 to 0.05Large 3.0 to 5.5 1.0 to 3.0 0.2 to 0.8 0.7 to 1.5 0.02 to 0.10

In the secure zone 337 the Z-axis depth of the needle slot 349 narrowsso as to compress against and orient the used needles 104 in parallelalignment with the needles 104 positioned across the width of the needleslot 349 and center portions of the used needles 104 spanning across theneedle driver slot 343. Once the needle 104 has been fully inserted intoand can proceed no further in the X direction the surgeon can releasethe used needle 104 in the secure zone 337 and this process can berepeated for the next used needle. The tip and trailing ends of the usedneedles 104 can be secured within the used needle slot 349 in the securezone 337 between the lower structure 341 and the upper structure 339.Once the surgery is completed or when the used needle trap 331 is fullor during a medical procedure, the used needles 104 stored in the needletrap 331 can be easily counted. In FIG. 168, seven used needles 104 areshown in the secure zone 337.

FIG. 169 illustrates a top perspective exploded view of the needle trap331 with a suture pack 101, FIG. 170 illustrates a side perspectiveexploded view and FIG. 171 illustrates a bottom perspective explodedview. The needle trap 331 may comprise an upper structure 339, lowerstructure 341, compressive members 347, foam connectors 357, entry zonesuture pack holder 351, and adhesive pad 355. A plurality of usedneedles 104 may be secured in the needle trap, and one or more suturepacks, such as suture pack 101 holding one or more suture needles 103,may be coupled to the suture pack holder 351 and/or the adhesive pad355.

The upper structure or front cover shell 339 comprises the top halfportion of the needle slot 343, and can be joined to the lower structure341 by adhesive bonding or ultrasonic welding. The upper structure maycomprise an injection molded clear polycarbonate, or other opticallytransparent material. The inner surface of the upper structure may haveprotrusions or nubs 361, also referred to as tactile bumps, intended toprovide separation between secured needles, to increase resistanceagainst the removal of secured needles, and to provide tactile feedbackduring translation of needles from entry or transitional zone into thesecure zone. The upper structure may includes 2-20 tactile bumps, 5-8tactile bumps, or 3-10 tactile bumps. The inner surface of the upperstructure may have a protruding needle stop 363, intended to preventneedles from being translated beyond the needle driver slot which wouldprevent accurate visual counting. The upper structure that covers thetransition zone 335 is flared at the boundary 345 toward the entry zone333 to present a deeper (z-axis) spatial target for fast location of theentrance to the trap with the needle driver.

The lower structure or rear shell 341 comprises the bottom half portionof the needle slot 343, and can be joined to the upper structure 339 byadhesive bonding or ultrasonic welding. The inner surface of the lowerstructure may have wells or recesses 359 within which the compressivemembers 347 may be adhesively attached. The recesses may decrease indepth within the transition zone from the entry zone to the secure zoneto increase compressive side load on needle ends. The deeper recesses atthe boundary of the entry and transition zones can prevent the end ofthe compressive members from being displaced by the needles duringtranslation. The outer surface of the lower structure can incorporaterecesses within which the foam connectors 357, adhesive pad 355, andsecure zone suture pack holder 351 may be adhesively attached. The wallsof the recesses can provide a standoff to provide separation between theneedle trap and barrier mounting surface for the needle driver tip. Thelower structure may comprise injection molded colored polycarbonate, ora material similar in composition to the material of the upperstructure.

Compressive members 347 can comprise open cell urethane foam stripsadhesively bonded to the lower structure 341. The compressive memberscan provide side load compression on the ends of the used needles alongthe secure zone.

The foam connectors 357 can provide an attachment interface between theneedle trap 331 and a barrier or platform as described herein. The foamconnectors may be adhesively attached within recesses to the outersurface or underside of the lower structure 341. Loop connectors may beadhesively attached to the exposed foam surface, which can extend abovethe recess walls and provide a means of attachment to corresponding hookconnector adhesively attached on the exterior barrier surface.

The secure zone suture pack holder 351 can provide a means topermanently attach a suture pack 101 next to the needle trap 331,providing a means for proximity reconciliation in real time by both thesurgeon and operating room assistants in the near surgical field. Thesuture pack holder may comprise a closed cell foam pad, adhesivelybonded to the outer surface of the lower structure 341. The exposed topsurface of the holder may be covered with pressure sensitive adhesivefor attachment to the rear surface of a suture pack. Loop connectors canbe adhesively attached to a raised surface 344 on the bottom surface ofthe suture pack holder, and provide a means to attach to a hookconnector on a barrier or platform as described herein.

The suture pack holder can be configured to flex between the needle trapand attached suture pack to enable the combined assembly to assume alower profile when mounted on the forearm by “tenting”. Alternatively orin combination, the suture pack holder can be coupled to the needle trapvia a hinge 346, as shown in FIG. 167. The hinge can reduce the profileof the assembly, by allowing the suture pack holder to “tent” about thehinge rather than extend straight up.

The adhesive pad 355 can be attached to the outer surface or undersideof the lower structure 341, underneath the entry zone. For example, theadhesive pad may be attached to the lower structure with pressuresensitive adhesive. The exposed surface of the adhesive pad can becovered with pressure sensitive adhesive providing a means to attach asuture pack 353 under the entry zone of the needle trap, along thelongitudinal axis of the forearm (x-axis). An additional piece of loopconnector may be attached to the underside of the suture pack 353, toenable additional stabilization of the suture pack by attaching to ahook connector on a barrier or platform as described herein.

The used needles 104 can be held in the needle slot 349 between an upperstructure 339 and a lower structure 341. Compressive members 347 can beplaced on the lower structure 341 below the needles 104 in the securezone 337. In an embodiment, an elastic and/or compressible member 347material can be foam, rubber, elastic plastic or any other suitablematerial or mechanisms that can be attached to the inner surfaces of thelower structure 341 facing the needle slot 349. In the illustratedexample, compressible member 347 can have a uniform thickness andleading edges of the compressive members 347 can be bend downward at theleading edge (towards the entry zone 333). In the illustratedembodiments, the compressive members 347 can fit within recesses 359 inthe lower structure 341. The leading edges of the recesses 359 can bedeeper than the other portions of the recesses 359 and this curvature ofthe compressible member 347 can provide a gradual narrowing of theneedle slot 349 as the used needles 104 slide over the compressiblemember 347 into the secure zone 337.

With reference to FIG. 171 a series of protrusions 361 can extenddownward from the upper structure 339 on both sides of the needle driverslot 343. As the needles 104 are inserted into the needle trap 331, thecompressible member 347 can press the needles 104 against theprotrusions 361. The protrusions 361 can resist the movement of theneedles 104 along the X-axis and prevent the needles 104 fromaccidentally sliding out of the secure zone 337 of the needle trap 331.A needle stop 363 can be positioned close to the end of the needledriver slot 343. The needle stop 363 can prevent the needles 104 frombeing placed away from the needle driver slot 343.

In different embodiments, the secure zone 337 can incorporate othertypes of retention systems. For example, the retention system caninclude a compressible member 347 which can be fabricated from: foam,Velcro loop or any other suitable media. The compressible member 347 canbe compliant and can compress the needles 104 against the bottom side ofthe upper structure 339 between retention features. The compressiblemember 347 can have a dimensional interference with the protrusions 361.In an embodiment, the density of the retention media material can beless than or equal to 4 lb. For example, the retention media materialcan be polyethylene or polyurethane foam which can provide a lowcoefficient of friction against a sliding needle 104.

In the illustrated embodiment, a suture pack 101 can be attached to asuture pack holder 351 that can be can be attached to the secure zone337 portion of the needle trap 331 with an adhesive. In anotherembodiment, another suture pack 353 with sutures 103 can be attached tothe entry zone 333 with an adhesive 355. The suture pack holder 351and/or suture pack 353 can provide a rigid base under the suture pack101 which can prevent the suture pack 101 from being bent while attachedto a forearm barrier or any other structure. Bending of the suture pack101 can result in loosening of needles 103 in their mounts which canpotentially result in a lost needle 103. The suture pack holder 351and/or suture pack 353 can is designed to either extend from or beattach as separate pieces to the needle trap 331. In an embodiment, thesuture pack holder 351 and/or suture pack 353 and the trap 331 can bemanipulated into a compact or flat space saving configuration forshipping and storage and then expanded into the illustratedconfiguration prior to use.

In an embodiment, the needle trap 331 and suture pack holder 351 and/orsuture pack 353 can be attached to another structure such as aprotective barrier worn on a forearm of a surgeon using variousdifferent types of connection mechanisms. For example, the needle trap331, suture pack holder 351, and suture pack 353 can be attached toanother structure such as a protective barrier with a hook and loopconnection mechanism. At least a portion of the protective barrier canbe covered with a hook material which can be adhesively bonded to theprotective barrier and back portions of the needle trap 331, suture packholder 351, and suture pack 353 can be adhesively bonded to a loopmaterial. In another embodiment, the needle trap 331 can be attached toa barrier or any other object with adhesive backed foam 357. In anembodiment the needle trap 331 can include one or more pieces coupled toa back surface of the lower structure 341.

Although the needle trap has been described and illustrated as having aspecific configuration, in other embodiments various otherconfigurations of components can be used to hold the needles in theneedle trap. For example in an embodiment, the compressive members 347illustrated in FIG. 176 can be replaced with elastic strips that aresecured in the secure zone on either side of the needle driver slot. Theelastic strips can include a plurality of elastic protrusions, which canextend up towards the upper structure. When the used needles are movedacross the exposed surfaces of the elastic strips with the needledriver, the protrusions can push the needles up against the upperstructure and the protrusions extending inward from the upper structure.These forces and protrusions can prevent the used needles from movingfreely within the secure zone of the needle slot.

In other embodiments, other mechanisms can be used to keep the usedneedles in the secure zone of the needle trap. For example, the usedneedle container can include magnets mounted on the upper structureand/or the lower structure on opposite sides of the needle driver slot.The needle driver can be used to move the used needles into the needleslot and when the needles are released, the magnets can hold and securethe needles within the secure zone.

With reference to FIG. 177, a front view of an embodiment of a needletrap 331 is illustrated. In the illustrated embodiment, the needle trap331 can include elastic materials 365 such as foam or other elasticmaterials coupled to the upper structure 339 and the lower structure 341on either side of the needle slot 349. When the needles 104 are placedin the needle slot 349 the elastic foam can contact opposite sides ofthe needles and prevent the needles from moving within the secure zoneof the needle trap 331.

Although the elastic material 365 is illustrated as having flat innersurfaces, in other embodiments, the elastic material 365 can havevarious surface features. For example with reference to FIG. 178 a crosssection side view of the needle slot 349 of the needle trap 331 isillustrated. The surfaces of the elastic material 365 that face theneedle slot 349 can include depressions or protuberances on the surfacefacing needle slot 349 in the secure zone 337. In the illustratedexample, the surfaces of the elastic material 365 can have rampedsurfaces which can be configured to allow the needle 104 to more easilybe moved into the secure zone 337 and resist the remove of the needles104 from the secure zone 337. The depressions and/or protuberances cancause the needles 104 to have a predisposition to seat at the properinterval positions in the secure zone 337. The depressions andprotuberances can provide positional cues for the surgeon with thesubtle force reduction to place and secure needles 104 at that thedesignated location.

With reference to FIG. 179 a top view of the secure zone 337 portion ofthe lower structure 341 in an embodiment of the needle trap 331 isillustrated. In the illustrated embodiment, the opposite sides of theneedle slot 349 can be lined with angled bristles 365 on opposite sidesof the needle driver slot 343. The bases of the bristles 365 can beattached to the outer side portions of the needle slot 349 and theremaining portions of the bristles 365 can bend relative to the bases.The arcuate needles 104 are moved through the secure zone 337 betweenthe bristles 365 and the bristles 365 can bend inward away from theneedle slot 349 to allow the needles 104 to be inserted into the securezone 337. However, the bristles 365 can prevent the needle 104 frommoving in the opposite direction because the bristles 365 would engagethe ends of the needle 104 which would move inward towards the needleslot 349 and resist the movement of the needle 104 out of the securezone 337. Thus, the bristles 365 result in less force to translate theneedle 104 from the entry zone 333 into the secure zone 337 than theforce required to remove the needle 104 from the secure zone 337.

A feature of the needle trap 331 is the ability to easily count needlesthat are placed in the secure zone 337. As illustrated in FIGS. 168 and172, the used needles 104 in the secure zone 337 of the needle trap 331are visible through the needle driver slot 117 and can be easilycounted. In other embodiments, the upper structure 123 can be made of atransparent or translucent material so that the used needles 104 can beviewed through the upper structure 123. In an embodiment, the usedneedles 104 can be counted by a second individual (other than thesurgeon) who is responsible for keeping track of the used needles 104.The needle trap 331 can allow the secured needles 104 to be visible froma distance so that the second individual can easily count the number ofneedles 104 in the needle trap 331. As discussed, the used needles 104can be positioned in parallel in the secure zone 337 with a spacing ofabout 3 mm to 10 mm between adjacent needles 104 to facilitate accurateneedle counting. In an embodiment, the needle trap 331 can have achamfered or filleted needle driver slot 343 edges can be colored orpainted to maximize reflectivity and provide a visual contrast toneedles 104 visible through the needle driver slot 343. For example, theedges of the needle driver slot 343 can be white.

FIGS. 172B-172D show top, side and end views, respectively, of theneedle trap 331 of FIG. 172A. Needle trap 331 comprises a housing 340 tocontain dispensed needles. The housing 340 comprises upper and lowerstructures as described herein.

Housing 340 defines needle slot 349, which comprises channel slot 349having an elongate cross section sized to receive the plurality ofneedles. The housing 340 comprises an overall length L, an overallthickness T, and a first width W1 comprising an overall width, and asecond width W2. The needle driver slot 343 comprises a width S toreceive needles. The driver needle slot comprises a length dimensionedlarger than a width of the slot to allow placement of a plurality ofneedles in the secure zone. The needle driver slot comprises a guide toguide the needle driver as the needle driver and needle are advancedalong the slot. An upper flange portion F1 and a lower flange portion F2extend from the housing 340. The upper flange portion F1 can be flaredupward to facilitate needle placement in the slot. Alternatively or incombination, the lower flange portion can be flared downward. The upperand lower flange portions may define a landing zone to receive needlesfrom a needle driver.

The transition zone of the needle slot is dimensioned larger than thesecure zone to facilitate placement of the needles in the needle slot.The elongate needle channel slot comprises a first elongate width CW1near an opening of the needle slot 349, and a second elongate width CW2in an interior secure zone of the needle slot. The elongate needlechannel slot comprises a first thickness CT1 near an opening of theneedle channel slot 349, and a second thickness CT2 in an interiorsecure zone of the needle slot. The first thickness CT1 can be at leastabout twice as thick as the second thickness CT2, for example.

The transition zone of the needle slot comprises a guide in order tofacilitate placement of the needles in the needle slot. The firstchannel width CW1 is dimensioned larger than the second channel widthCW2 in order to provide a larger entry zone to receive needles andfacilitate placement of needles in the secure zone. The second channelwidth CW2 is dimensioned to receive the plurality of needles arranged ina row in the secure zone. The needle slot channel comprises a firstthickness CT1 and a second thickness CT2. The first channel thicknessCT1 is dimensioned larger than the second thickness CT2 in order tofacilitate placement of needles in the secure zone comprising secondthickness CT2. The second thickness CT2 can be dimensioned smaller thana thickness of the needles as described herein in order to contain theneedles with at least some mechanical resistance and deformation of oneor more interior structures, such as a surface or protrusions of theinterior surface. The first thickness CT2 is dimensioned larger than thethickness of the needles placed therein in order to easily place theneedles in the transition zone.

In many embodiments, the needle trap is configured to provide at leastsome resistance to the needle sliding along the needle slot in thesecure zone, in order to stabilize and render innocuous the needle inthe secure zone, such that the needle is secured. One or more of theupper or lower structures of the needle slot can be configured todeflect when the needle is advance into and placed in the secure zone,for example. Alternatively or in combination, the interior of the needleslot channel may comprise structures configured to one or more ofdeflect, deform, stretch or bend within the secure zone in order tostabilize the needles within the secure zone.

In some embodiments, the resistance of the needle driver along theneedle driver slot is less than the resistance of the needle along theneedle slot when the needle is advanced along the slot with a needledriver.

In some embodiments, the resistance of the needle receptacle against theneedle driver is less than the resistance of the needle receptacleagainst the needle.

In some embodiments, the force imparted by the needle driver slotagainst movement of the needle driver is less than the force imparted bythe needle slot against movement of the needle.

In some embodiments, the force imparted by the needle receptacle againstmovement of the needle driver is less than the force imparted by theneedle receptacle against movement of the needle.

In some embodiments, the friction force between the needle driver slotor slit and the needle driver is less than the friction force betweenneedle slot and the needle.

In some embodiments, the friction force between the needle receptacleand the needle driver is less than the friction force between the needlereceptacle and the needle.

Although reference is made to dimensions of the needle trap having asubstantially flat configuration, the needle trap can be configured inmany ways. For example, the needle trap 331 may comprise a conformalmaterial that allows the needle trap to be bent or curved, for example.

In other embodiments, additional devices can be used with the needletrap 331 to facilitate remote counting and tracking of needles. Withreference to FIGS. 180 and 181, in other embodiments, the needle trapcan include an electronic needle counter that can be powered by abattery 373 such as a lithium ion battery or any other suitableelectrical power source. Conductive elements 371 can be mounted in theneedle slot on the compressive members 347 on opposite sides of theneedle driver slot. The conductive elements 371 can be pressed intophysical contact with each needle 104 that is placed in the secure zone337 by the compressive members 347. The electrical counter mechanism caninclude control circuitry 375 and a visual display 377 coupled to thecontrol circuitry 375.

The electrical counter mechanism can comprise an electrical circuit withelectrical current flowing through the needles 104 in the secure zoneand the control circuitry 375. The electrical resistance changes basedupon the number of needles 104 stored in the secure zone in contact withboth of the conductive elements 371. The electrical circuit can have ahigher electrical resistance with fewer needles 104 in the secure zone.The electrical resistance can decrease with more needles 104 in thesecure zone. Each of the used needles 104 can each have an electricalresistance between the conductive elements 371 that is substantially thesame. Thus, each of the used needles 104 can function as a resistor inthe electrical circuit and multiple used needles 104 in the secure zonecan function as a plurality of parallel resistors.

The basic electrical circuit equation is V=I R where V is voltage, I iscurrent and R_(total) is the cumulative needle resistance. Thecumulative electrical resistance can decrease with each additionalstored needle in the secure zone. The equation for parallel resistors is1/R_(total)=1/R₁+1/R₂+1/R₃ . . . . However, the resistances of theneedles can all be substantially equal, i.e. R₁=R₂=R₃ where R₁ is theelectrical resistance of each used needle. The cumulative electricalresistance needles equation becomes 1/R_(total)=N/R₁ or R_(total)=R₁/Nwhere N=number of needles. Thus, the number of needles can be calculatedwith the electrical circuit by V=I R₁/N or N=I R₁/V. Changes in thecumulative resistance and impedance of the parallel needles can alterthe electrical current flowing through the electrical circuit. Thevoltage V and R₁ values can be substantially constant. Thus, changes inthe electrical current (I) are based upon the number of parallel needlesin the secure zone. The control circuitry 375 can include an ammeterthat measures the electric current (I) in the circuit and based upon themeasured current, the control circuitry 375 can calculate the number ofneedles in the secure zone. The control circuitry 375 can output asignal to the visual display 377 that corresponds to the number ofneedles in the secure zone. In an embodiment, the number of needles Ncan be displayed on the visual display 377. With reference to FIG. 180the visual display 377 can display the number “1” which corresponds tothe single needle 104 between the conductive elements 371. Withreference to FIG. 181, the visual display 377 can display the number “5”which corresponds to the five needles 104 between the conductiveelements 371. In other embodiments, the visual display 377 can outputany other display that can indicate the number of needles in the securezone. For example, the display can use individual lights to representeach needle. Each needle in the secure zone can be represented by asingle corresponding illuminated light.

With reference to FIGS. 182-184, in an embodiment, mechanical counterdevices can be used with the needle trap 331 to facilitate needlecounting. In the illustrated embodiment, an arm can be actuated to causea numerical indicator to advance the number displayed. In FIG. 182, asingle needle 104 has been placed in the needle trap 331 and the visualdisplay 377 shows “1”. With reference to FIG. 183, a second needle 104can slide through the needle slot 349 and contact the arm 379 whichrotates about an axis and actuates the visual display 377 to advance thedisplayed number. With reference to FIG. 184, after the second needle104 passes the arm 379, the display 377 has changed to “2” and the arm379 has reset to its normal position detect the next needle 104.

As discussed, the middle portions of each of the needles in the securezone 337 of the needle container 201 are visible through the needledriver slot 343 which can also function as a window. Counting of needles104 can be improved by fabricating a needle container 201 from a clearcasing and clear foam materials an embodiment of which is shown in FIG.185. Depressions 379 in the needle slot 349 boundary surface compressivemembers 347 can provide individual locations for each of the usedneedles. In different embodiments, the compressive members 347 can befoam or any other suitable materials. The used needles 104 can sit inthe depressions 379 which can be used as a visual indicator(s) of thenumber of needles 104 stored in the secure zone 337. A dye may beapplied such that with compression of the compressive members 347 when aneedle 104 is stored can cause the color of the compressive members 347in the compressed area in contact with or adjacent to the needles 104 tochange. In the illustrated example, the needles 104 in the depressions379 can result in a red color marking. A portion of foam or material maybe normally hidden in the compressive members 347 but as the needle 104presses against the dyed material in the depressions 379, the dye(s) canbe released, combined, actuated or any other process that can cause thesurface of the depressions 379 where needles 104 are stored to becolored and become visible.

In another embodiment, a visible red dot can appear wherever a needle ispresent in the secure zone and each dot can represent a different needlein the secure zone. In other embodiments, different color dyes can beused with some or all of the needle depressions. It can be easier tocount different colored dye markings or alternatively, if the dyes arearranged in a repeating sequence. For example a first needle positiondepression can be red, a second needle depression can be blue, a thirdneedle depression can be green, a fourth needle depression can be purpleand a fifth needle depression can be yellow. This color sequence canrepeat for all subsequent depressions in groups of five or any othernumeric interval of depressions. Thus, a sixth needle and eleventhneedle depressions can be red, a seventh and twelfth needle depressionscan be blue, etc.

In an embodiment with reference to FIG. 186, an optical countermechanism can be used with the needle trap to indicate the number ofstore needles 104. An optical scanner(s) 381 can be used to detect thenumber of needles 104 that are stored in the secure zone 337 of theneedle trap 331. The scanner 381 may also be designed to operated inother areas of the radio frequency spectrum such as infrared, UV, radaretc. for the counting function. In another embodiment, a reflectivescanner can be used to quantify amount of metal from strength ofreflected or transmitted optical signal. In an embodiment an infraredimage can detect needles in the needle trap 331 with better accuracythan visual counting from a standard optical image of the needle trap331. The plastics and foam components of the needle trap 331 cantransmit infrared energy whereas the metal needles 104 can reflect theinfrared energy. The optical scanner 381 can transmit scanned needleinformation to a processor 383 that can convert the scanned signal intoa number representing the number of needles 104 in the secure zone 337of the needle trap 331. The processor 383 can be coupled to a visualdisplay 377 that can be controlled to display the number of detectedneedles in the secure zone 337 of the needle trap 331.

With reference to FIG. 187, a camera(s) 385 can be used to detect thenumber of needles 104 that move into the secure zone 337 of the needletrap 331. The cameras can be coupled to a processor 383 that receivesneedle count signals as each needle 104 passes over the camera(s) 385.The processor can count and store the needle count signals and output aneedle count signal to the visual display 377 which can display thenumber of detected needles 104 in the secure zone 337 of the needle trap331. In different embodiments, different types of cameras 385 can beused. For example, the needles 104 can be more visible to an infraredsensor than a visual wavelength optical camera. Thus, an infrared camera385 may more accurately detect the movement of needles 104 into thesecure zone 337.

With reference to FIG. 188, in an embodiment the system can detect thenumber of needles in the secure zone 337 of the needle trap 331 basedupon pressure measurements detected by transducers 387. In theillustrated embodiment, the needle trap 331 transducers can detectcompressions in the compressive member 347 caused by the needles 104.The transducers 387 can be positioned along the length of the securezone 337 and the protrusions 361 can create individual needle storageareas. By measuring the increased pressure in each of the needle storageareas, the number of needles 104 in the secure zone 337 can bedetermined. The transducers 387 can be coupled to a processor 383 whichcan determine the number of used needles 104 in the secure zone 337based upon the transducer 387 signals and the processor 383 can transmita needle count number signal to the visual display 377 which can displaythe needle count number. In different embodiments, different types oftransducers 387 can be used to detect the needle pressure. For example,the transducers 387 can be can be piezoelectric devices that can also beused in which pressure applied to compressive member 347 and records thepresence of each needle 104. Alternatively, the transducers 387 caninclude a series of strain gages that may be utilized to sense thepresence of needles 104 in the secure zone 337 or any other suitablepressure detecting mechanisms.

With reference to FIG. 189, in other embodiments, the needle trap 331can be used with other components to perform needle counting. In theillustrated example, the needle trap 331 can be mounted on a barrier 403that can be placed on a forearm of a surgeon. A needle sensor 389 candetect needle count signals and the needle count signals can betransmitted by a transmitter 391 to a receiver(s) 393 which can becoupled to a processor(s) 383 which can output needle count informationto an output device 395 which can indicate the number of needles in theneedle trap 331. In the illustrated embodiment, the needle sensor 389can be a small camera with an integrated radio frequency (RF)transmitter 391 which transmits image and/or video RF signals toreceivers 393. A processors 383 coupled to the receivers 393 can outputimage and/or video signals to visual displays 337 which can display theneedle driver slot 343 to allow the needles 104 to be visually countedremotely. The needle sensor 389 and transmitter 391 can be within thenear surgical field. In contrast, the receivers 393, processors 383 andvisual displays 337 can be well outside the near surgical field.

The camera can face the needle trap 331 and also possibly the suturepack(s) 101. The images of the needle trap 331 can be transmitted to thevisual display(s) 337 which can be visible to another person. Forexample, the remote visual display(s) 337 can be a video display mountedon an operating room wall. As discussed, a portion of each of theneedles 104 is visible from the upper surface of the needle trap 331through at least the needle driver slot 343. Thus, a displayed image ofthe needle trap 331 on the surgeons forearm can show the number of usedneedles 104 in the needle trap 331 and new suture needles 103 in thesuture pack 101. A surgical assistant can view the display 337 and seethe suture pack(s) 101 and the needle trap 331 with the secured needles104 to track in real time. The surgical assistant can then provideadditional suture packs 101 if additional needles 103 are required andprovide new empty needle traps 331 as the barrier mounted needle traps331 become full of used needles 104 and needs to be replaced. Also, if aneedle 104 is lost the error can immediately be detected by someonemonitoring the surgical procedures or by the processor which can detectthe sequential removal of new needles 103 from the suture pack and thedeliver of the used needles 104 to the needle trap 331. Although anexemplary set of system components has been described, in otherembodiments, the needle count components can include but are not limitedto: dedicated receivers, electronic watches, smartphones, tables,computers, headsets, earpieces, displays, or any other suitable devicefor the purpose of tracking the needles.

As discussed, mid-bodies of needles 104 are visible through the needledriver slot 349 in the needle trap 331. In an embodiment, the processor393 can run a software program that can interpret the visual displaysignals from the needle sensor 389 (camera) and determine the number ofneedles 104 in the needle trap 331 as well as the needles 103 in thesuture pack 101. The processor 393 can then output this needle countnumber on the visual display 377 which can help with the needle countingprocess. In other embodiments, the needles 104 can include markings 397or transmitters that can help track the needles 104. In an embodiment,the markings can visual codes such as bar codes, quick response (QR)codes, color codes, numeric markings or any other markings which canprovide at least some identification information about the needles 104.The markings can be placed on the middle body portion of the needles104. When the needles 104 are placed in the needle trap 331, themarkings can be visually detected through the needle driver slot 349 inthe needle trap 331 by an optical sensor such as a scanner or a camera.In an embodiment, an optical needle sensor 389 can detect the markingsand the processor 383 can interpret the markings and determine theidentifications of the needles 104 based upon the markings. Thisidentification information can then be used for needle tracking andneedle reconciliation. The identification information can also be outputto the visual display 377.

In other embodiments, other mechanisms can be used for needle tracking.For example, in an embodiment the needles 104 can include embeddedelectronic components such as a radio frequency transmitter such as aradio frequency identification tag (RFID) which can transmit an RFidentification signal in response to exposure to an interrogating radiowave. In an embodiment with reference to FIG. 189, the needle sensor 389can include an interrogating radio wave transmitter and an RF receiver.When exposed to the interrogating RF waves, the RFID tags on the needles104 can emit RFID signals that can be detected by the RF receiver. TheRFID information can be transmitted to the processor 383 which can thenidentify each needle in the needle trap 331.

In other embodiments, the suture packs 101 can also have integratedtracking mechanisms. For example, the suture packs can include an activeelectronic sensor that can be activated when suture pack is opened. Thisactive signal can be transmitted to a processor off the surgical fieldthat can monitor the use of the suture packs and know which needles mustbe reconciled after the suture pack is used. In an embodiment, theseactive signals can be transmitted wirelessly from a suture pack or asuture pack sensor to a remote receiver. These active signals can beprocessed by a processor as described above. This feature can allow theneedles to be tracked from the suture packs to the needle trap in aclosed loop manner to further insure that all needles are accounted for.

In another embodiment, the tracking of the needles can be done morelocally on the barrier which can be mounted on the forearm of thesurgeon. In this embodiment, a processor can be mounted on the barrierand the processor can keep track of the locations of all needles throughout the surgical procedure. An active signal can identify a suture packthat is being opened and the identities of all of the needles in thenewly opened suture pack. The system can identify the movement of eachof the needles from the suture pack through a patient and into theneedle trap. If a needle is lost the processor that can output an errorsignal to an output device such as a visual display or audio outputdevice can immediately detect the error. If possible, the surgicalprocedure can be temporarily stopped until the lost needle is found. Thedescribed needle tracking can also provide useful needle trackinginformation that can be stored in a data center and the number ofneedles in the near surgical field can be automatically reconciled inreal time. As needles are secured in the needle trap, the system canbroadcast correlation information for needle reconciliation.

In another embodiment, the suture dispenser and needle trap can becombined onto a single mount that attaches to the proximal end of asurgical tool such as forceps. Such configurations can allow attachmentto the slotted shape of the forceps with adequate mechanical integritysuch as to avoid displacement with the mechanical forces anticipatedduring manipulation of the tools against the needle trap.

In an embodiment the suture dispenser and needle trap can be attached tothe surgical tool with a mechanical clip that secures a sufficientlength of the suture dispenser and needle trap to the tool (forceps)base to provide rotational and translational stability. In anotherembodiment, the clip can contain adhesive mounts. In another embodiment,magnets can augment the secure attachment of the suture dispenser andneedle trap to the forceps.

In other embodiments, the needle trap and/or suture dispenser can beattached to the surgical drapes covering the patient and can bepositioned adjacent to the wound. In an embodiment the suture dispenserand needle trap are mounted on a protective platform that securesposition on drapes and the platform can be secured to the drapes with anadhesive or any other suitable coupling mechanism.

The suture pack dispensers can have multiple configurations and designs.In an embodiment, suture pack dispensers can secure existing suturepacks to the barrier. In other embodiments, needles with attached sutureare secured in a structured array for easy access by the surgeon. Inanother embodiment, non pop-off suture needles are compatible with thesuture packs and suture pack dispensers. The non pop-off needles caninclude but are not limited to swaged on needles, running sutureneedles, barbed running suture needles, etc. These needles can be usedfor creating multiple surgical knots and/or for running sutureapplication that can be dispensed as single or double needles.

In an embodiment, a spool can be attached to the forearm mount orbarrier for securing the running needle. This embodiment can includemultiple spool mounts attached to the barrier for the forearmconfiguration, or to the instrument clip construct for the forcepsattached device. In an embodiment the suture spools can be stacktogether for lower profile. In another embodiment the spool can allowfor rotation for easier dispensing of the suture. Multiple mechanismsfor securing the needle, which is attached to the thread wound aroundthe spool, can includes mechanical, adhesive, magnetic mechanisms andmultiple needle enclosure designs.

Used Needle Receptacles

In many embodiments, various types of used needle receptacles can bemounted on any of the disclosed barriers and platforms. With referenceto FIG. 190, a used needle receptacle 257 can be an open top box 260with a foam 263 layer having numeric markings 259 secured within the box260. Used needles 104 can be placed in the foam 263 in a sequence andareas that correspond to the numeric markings 259. There are variousproblems with this type of used needle receptacle 257. While the distalends of the needles 104 are placed in the foam 263, the proximal end ofthe needles 14 are exposed and can be dangerous. The foam 263 can have adurometer or density that is still enough to resist displacement of theneedles 104 (angulatory and/or translatory) which potentiates injury.The needles 104 can protrude beyond the upper edge height limit of theopen top box 260 container which can create a safety issue. If thecontainer walls are higher than the needles 104, this higher height canmake the placement of the needles 104 more challenging especially whenthe box 260 is against a lateral wall. If an open top box 260 usedneedle receptacle 257 were placed on the user's arm without a barrier,the downward motion needed to stick the needle 104 into the foam 263could potentiate injury and this potential injury can be more likely ifthe surgeon tends to “swipe” the needle 104 into the surface, foam 263.A swipe needle 104 insertion can include a combination of horizontaltranslation, rotation and downward forces. The numeric markings 259 canbe small target areas that not optimal or easily hit with a used needle104 if a surgeon is trying to expedite the insertions of used needles104. Further, the small target areas associated with the numericmarkings 259 can be easily missed. There can also be a tendency toinsert a used needle 104 wherever there is an open spot on the foam 263layer rather than the designated locations. It may be better tosegregate the used needle areas on the foam 263 into limited anddistinct zones that may contain five needles 104 at most.

In an embodiment with reference to FIG. 191, it can be possible toimprove the safety of open top box 260 used needle receptacles 257 byadding a transparent dome 262 that can be coupled to multiple sides ofthe open top box 260 as well as open sides which can allow the placementof needles 104 into the foam 263. The transparent dome 262 can providemany benefits over a normal open top box 260 design. The transparentdome 262 can prevent or reduce the risk of inadvertently contactingproximal needle 104 ends which are sharp enough to tear a glove.Transparent dome 262 can also enable visual counting of the used needles104. If needles 104 are not fully fixed into the foam 263, the partialsurrounding container provided by the dome 262 makes losing a looseneedle 104 less likely. Because needles 104 are covered it can bepossible to insert a crimped proximal end of the used needle 104 intothe foam 263 (depending on durometer or density) and the dome 262 wouldprevent the sharp distal end of the needle 104 from causing injury.

In an embodiment, the box 260 with transparent dome 262 could be mountedon a platform or barrier on a forearm of a surgeon. When the used needle104 is used to install a suture and is then placed in the used needlereceptacle 257, the surgeon can hold the used needle 104 with a needledriver, place the needle 104 into the used needle receptacle 257 thoughan opening under the dome 262. The surgeon can then insert the needle104 into the foam 263 and rotate the needle driver and needle 104 tofully insert the needle 104. The initial motion of inserting the needle104 can be tangential to the forearm and there can be a lower likelihoodof missing the foam 263 and causing injury. However, there can beproblems with this configuration. Because the dome 262 makes the foam263 less accessible, it can be difficult to properly place the needles104 in an organized manner unless significant effort and attention toneedle 104 placement is performed by the surgeon. Also, the needles 104placed closest to the dome 262 opening may possibly project the proximalends out of the needle receptacle 257 from the opening which canpotentiate injury since they may not be covered by the dome 262.

In another embodiment as illustrated in FIG. 192, a used needlereceptacle 257 can have an open top box 260 that has a smaller foam 263area and can be covered by a transparent dome 262. This smaller box 260size may only allow a limited number of needles 104 to be placed in thereceptacle 257. In an embodiment, the smaller box 260 size may belimited to storing a maximum number of used needles 104, such as 5-10used needles 104. The smaller size can also allow for a Lower profiledome 262. When this used needle receptacle 257 is used, the needle 104can be placed through the opening on the side of the dome 262 androtated to drive the needle 104 into the foam 263. This insertion androtation motion can improve safety particularly when the used needlereceptacle 257 is mounted on a forearm of a surgeon. However, thesmaller size can limit the number of needles 104 that can be containedbefore the used needle receptacle 257 becomes full. Proximal ends ofneedles 104 that are stored close to the dome 262 opening can be exposedif the needle 104 is inserted at an angle into the foam 263. Dependingon the durometer or density of the foam 263 it may or may not bepossible to insert the needles 104 proximal crimped end into the foam263 given that the needle 104. The clear dome 262 can allow the needles104 to be easily counted.

With reference to FIGS. 193 and 194, another embodiment of a used needlereceptacle 257 is illustrated. In this embodiment, an open top box 260is placed within a dome 262 that is at least partially transparent.Rather than having open sides, the dome 262 can have an elongatedopening 256 that can be longer than the length of the longest needle 104to be stored. Needles 104 can be held with a needle driver and insertedthrough the elongated opening. The needle 104 can then be positionsabove the foam 263 and rotated to drive the distal end of the needle 104into the foam 263. Once the needle 104 is securely placed in the foam263, the needle 104 can be released and the needle driver can be removedfrom the elongated opening 256.

With reference to FIG. 195, an embodiment of a used needle receptacle257 can include an open top box 260 and magnets 287 mounted on a floorof the box 260. In the illustrated example a plurality of discrete diskmagnets 287 can be mounted a transparent base of the box 260 which canenable easier needle 104 counting. The spacing between adjacent magnets287 can enable magnet-free zones so that needle driver contactmagnetization is minimized. In an embodiment, the polarities of themagnets 287 poles facing outward can be alternated to also minimizemagnetization of needle drivers. When inserted, the needles 104 lie flator horizontal relative to the floor of the box 260 rather than inperpendicular orientations which can be safer because the ends of theneedles 104 may not protrude above the upper edges of the box 260. Sincethere is not an opening to insert the needle 104 though, this usedneedle receptacle 257 can accept all needle 104 sizes. It can also beeasy to use by quickly dropping needles 104 onto the magnet 287 whichwill retain the needles 104 with magnetic attraction. However, becausethe needles 104 may not be stored in any order or pattern, there can bea lack of needle 104 organization making it more difficult to count thestored needles 104. When the used needle receptacle 257 a scrubtechnician might need to take time to rearrange the needles 104 forcounting which can require additional time and more needle 104 handling.There can be additional risks of needle 104 sticks with additionalhandling. The needle 104 can often be relatively orthogonal to theneedle driver and it may be hard to appose the needles 104 with the box260. In an embodiment, the used needle receptacle 257 can be mounted onthe non-dominant forearm of a surgeon and the used needle receptacle 257can be positioned in space to facilitate needle 104 placement onto thesurface of the magnets 287.

In other embodiments, a used needle receptacle 257 can include bothmagnets 287 and foam 263. In an embodiment with reference to FIGS. 196and 197, the used needle receptacle 257 can also be oriented verticallyrelative to a forearm barrier or platform with the open top of the box260 facing proximally. In this orientation, the needle driver can placethe needle 104 substantially parallel to a planar floor of the box 260while being held by the surgeon. The needle driver can then easilyrotate so the sharp distal end of the needle 104 is driven into the foam263. The magnets 287 can allow the needles 104 to lie flat within thebox 260 in vertical orientation. The needles 104 can be inserted androtated into the foam 263. In different embodiments, the used needlereceptacle 257 can include any combination of magnets and foam. Forexample, a first embodiment can only include magnets 287, a secondembodiment, can only include foam 263 and a third embodiment can includeboth magnets 287 and foam 263. The vertical orientation of the box 260of a forearm barrier can have an improved safety aspect because theforces and motions are not directed toward the forearm. The needles 104are I insert into the box 260 and then rotated and translated into thefoam 263. The box 260 can be made of a clear material and the clearfloor of the box can allow for needle counting from both sides of thebox 260.

With reference to FIG. 198, an embodiment of a used suture needlereceptacle 257 can include a combination of magnets 287 and foam 263 invertical orientation. In the illustrated embodiment, the box 260 can bedivided into two adjacent areas. In other embodiments, the used sutureneedle receptacle 257 can include 3 or more adjacent needle storageareas. In other embodiments, the foam 263 can be angled to optimizeergonomics of the needle 104 rotation and fixation. In an embodiment, aneedle 104 can be placed on each of the spaced magnets 287 and each ofthe magnets 287 can be numbered in order to maintain needle 104organization and to facilitate needle 104 counting.

With reference to FIGS. 200 and 201 another embodiment of a used sutureneedle receptacle 257 is illustrated which can include a halfcylindrical housing 295 which can be made of a transparent material. Thehousing 295 can have a half circle shaped insertion slot. The needlescan be placed in the used suture needle receptacle 257 in a low profilearray of needles extending front to back. The used suture needlereceptacle 257 can incorporate an insertion offset zone between outeropening and foam 263 inside container housing 295. The insertion zonecan be offset from foam 263 to ensure that the entire needle 104including the proximal end is fully enclosed within the housing 295. Ifthe needle 104 is inserted at an angle into the foam 263, the proximalend of the needle 104 is less likely to extend out of the housing 295when there is a sufficient insertion offset zone.

The used suture needle receptacle 257 can be mounted on a platform withthe opening facing away from the platform. The cylindrical geometry ofthe used suture needle receptacle 257 enables the housing 295 to berotated in the mounting plate to present the foam 263 at optimal anglefor both forehand and backhand needle driver rotation which can beeasily used by both left and right handed users. The size of the openingmay provide safety features. A hand or a fingertip is less likely to beaccidentally inserted into a smaller opening than a larger opening andinjury is less likely. In an embodiment, it is possible to have a largernumber of smaller containers with each container limited to 5 needlesper housing 295. The illustrated design of the housing 295 can alloweither end of the needle 104 to be inserted into the foam 263.

With reference to FIG. 202 another embodiment of a used suture needlereceptacle 257 is illustrated. An opening in the housing 295 can have anoval entry slot that can decrease the profile of the used suture needlereceptacle 257 which can require the needle 104 to be tilted to enterthe housing 295. The illustrated embodiment can incorporate a needleentry offset zone between outer opening and foam 263 inside housing 295.The foam 263 can be mounted on a top portion of the housing that enablesneedle 104 rotation and fixation from either side of the foam 263. Foam263 material can be used that has a consistency and hardness that canallow for penetration by proximal or distal ends of the needles 104. Theneedles 104 can be inserted into the used suture needle receptacle 257in an upside down orientation. Because the exposed end of the needle 104will be below the upper surfaces of the housing 295 and close to thebarrier or platform the chances of user contact with the needle 104 areminimal. Even if a proximal end of the needle is projecting from thehousing 295 a hand would normally strike the needle with a downwardmotion and there would be little counterforce to cause the needle 104 topenetrate through a glove because the needle 104 is suspended in air.This isolation of the needle can allow lower durometer or density foamto be used which can be easier for the needles 104 to penetrate. Thisconfiguration can allow more needles 104 to be held by the used sutureneedle receptacle 257 because needles 104 can be inserted into oppositesides of the foam 263 rather than just through one side. Although theopening is illustrated as an oval shape, in other embodiments, theopening could be more triangular, tear drop or a keyhole. The wider baseof the illustrated embodiment can provide greater stability and indifferent embodiments, the used suture needle receptacle 257 can bemounted on the forearm or on the surgical field, on the patient.

With reference to FIGS. 203 and 204, an embodiment of a used sutureneedle receptacle 257 is illustrated that can have a slot slide boxhousing 295, a needle slot 349, a needle driver slot 343, a layer of topfoam 263 and a lower of bottom foam 263 on opposite sides of the needleslot 349 and an opening for inserting the used needles 104. In thisembodiment, the user can grasp the needle 104 and place the needle 104through the opening. Once the plane of the needle 104 is adjacent to thelower needle slot 349 surface the user can slide the needle 104 into thecovered portion of the needle slot 349 with the needle driver movingthrough the needle driver slot 349. The needle 104 can be compressed andheld in the needle slot 349 by the top foam 263 and bottom foam 263. Thefoam 263 on the top and bottom surface of the slot can enable insertionby both forehand and backhand needle driver rotation and either left- orright-handed needle driver use. The used suture needle receptacle 257can incorporate an insertion offset zone between outer opening and foam263 inside container. Like the needle trap embodiments, the needles 104can be organized and stored in an array in side-side orientationallowing for thin profile. Although the opening is illustrated as beinglarge and round, in other embodiments, the opening can be narrowerkeyhole shape that requires insertion and rotation through the openingbefore moving the needle 104 into the more secure needle slot 349. Theillustrated left and right needle slot 349 configuration can allow theneedles 104 to be more easily aligned and moved into the needle slot349.

With reference to FIG. 205, another embodiment of the used suture needlereceptacle 257 is illustrated. In this embodiment, the needle 104 can beplaced through a slot 256 in a housing 295 so that the distal sharp endis pressed into foam 263. The housing 295 can be coupled to an angledstructure that can help to guide the needle 104 into the foam 263.Magnets 287 can be mounted under a planar structure adjacent to the slot256 which can hold the proximal end of the needle 104 against the planarstructure so avoid having proximal end of the needle 104 positioned inspace which can

FIGS. 223-224 illustrate an embodiment of a used suture needlereceptacle 257 that can include a cylindrical housing 295 having anopening 256 on one end. An elongated foam 263 structure can be mountedto a bottom portion of the cylindrical housing 295. To store a needle104 in the receptacle 257, the needle driver can insert the needle 104into the housing until the needle is adjacent to the foam structure 263.The needle driver can then rotate the needle 104 to insert the needle104 into the foam structure 263. Once the needle 104 is securely held bythe foam 263, the needle driver can release the needle and the surgeoncan remove the needle driver from the housing 295. This insertionprocess can be described very generally as “insert and rotate” meaningthat the needle is first inserted and then rotated to secure the needle104 to the foam 263 in the receptacle 257. FIG. 225 illustrates a sideview of the housing 295. The foam 263 can be recessed within the housing295 away from the end opening 256. This offset space between the outeropening 256 and the foam 263 can be known as an “insertion offset zone”.If the needle 104 is inserted at an angle into the foam 263, theproximal end of the needle 104 is less likely to extend out of thehousing 295 when there is a sufficient insertion offset zone.

FIGS. 226-228 illustrate an embodiment of a used suture needlereceptacle 257 that is very similar to the embodiment illustrated inFIGS. 223-225. FIGS. 226 and 227 illustrate front views of thereceptacle 257 and FIG. 228 illustrates a side view. In the illustratedembodiment, the foam 263 if mounted on an upper inner surface of thehousing 295. Thus, the needle 104 must be positioned so that theinsertion end of the needle 104 is adjacent to the upper foam 263. Theplacement of the foam 263 on the upper portion of the housing 295 canhave some safety benefits. If the receptacle 257 is normally in theupright position, the needles 104 in the foam 263 will dangle downwardand gravitational forces on the needles 104 will tend to maintain thisneedle orientation. If a portion of a needle 104 extends out through theopening 256 of the housing 295, contact with the needle 104 can normallybe a downward impact which can cause the needle 104 to rotate into thedownward orientation and possibly move the exposed end of the needle 104into the housing 295. In contrast, if a portion of the needle 104 isexposed in the “lower foam” 263 embodiment, a downward impact with anexposed end can cause the needle 104 to rotate further out of thehousing 295. Further, because the portion of the needle 104 in the foam263 can provide resistance to a downward impact, contact with theexposed portion of the needle 104 can cause injury to the object thatcontacts the needle 104.

With reference to FIG. 229 a front view of another embodiment of a usedsuture needle receptacle 257 is illustrated. In this embodiment, thehousing 295 can include a transparent dome 262 and foam 263 pieces onopposite sides of the transparent dome 262. The foam 263 can includemultiple surfaces into which the needles 104 can be inserted. Thus, theneedles 104 can be inserted into any exposed surface of the foam 263pieces with either the concave or convex sides facing up. With referenceto FIG. 230 a top view of the embodiment of the used suture needlereceptacle 257 is illustrated. The foam 263 can be offset inward fromthe opening 256 in the housing 295 by the insertion offset zone for thesafety reasons described above.

With reference to FIG. 231 a side view of an embodiment of a used sutureneedle receptacle 257 which can have a cylindrical housing 295 with oneclosed end and an opening 256 which is an open end of the housing 295.FIG. 232 illustrates a front view of the embodiment of the receptacle257. An elongated strip of foam 263 can be attached to an inner surfaceof the housing 295 along the length of the housing 295. In theillustrated embodiment, the foam 263 extends out of the housing 295 andwraps around the edge of the opening 256 and along a portion of theouter surface of the housing 295. To use the receptacle 257, a needlecan be held with a needle driver such that the curvature of the needlecan be aligned with the curvature of the housing. The needle driver caninsert the needle through the opening and into the housing 295 with anend of the needle facing the foam 263. When the needle is positioned atthe desired insertion point, the needle driver can be rotated to drivethe needle into the foam 263. Once the needle is securely held by thefoam, the needle can be released by the needle driver which can then beremoved from the receptacle.

The needle traps 331 illustrated and described with reference to FIGS.223 to 232 can all utilize an insertion process can be described verygenerally as “insert and rotate.” Each of the illustrated needlereceptacles 257 can have a housing 295 having a longitudinal axis thatcan extend from the opening 256 through the center of the housing 295. Aneedle can be held with a needle driver in an orientation that isroughly perpendicular to the longitudinal axis of the needle receptacle257. The needle 104 insertion movement into the housing 295 can besubstantially parallel to the longitudinal axis. The needle 104 can beinserted until a tip of the needle 104 is aligned with a desiredinsertion point on the elastic member 263 which can be made of foam orany other suitable material. At the insertion point, the needle 104 canbe rotated about the longitudinal axis, meaning that the axis ofrotation of the needle 104 can be parallel to the longitudinal axis ofthe needle receptacles 257. The needle 104 can be inserted into theelastic member 263 to secure the needle 104 within the receptacle 257and the needle driver can release the needle 104.

With reference to FIG. 206, a plurality of used suture needlereceptacles 257 can be coupled to a movement control mechanism within ahousing 295. The housing 295 can have an opening 256 so that at leastone of used suture needle receptacle 257 can be accessible through theopening 256. In the illustrated example, the receptacles 257 move in alinear manner with the upper row moving right and the lower row movingleft. The movement can be controllably moved so that the surgeon willalways be able to place used suture needles in an empty or onlypartially full used receptacle 257 that is accessible through theopening 256. When the exposed receptacle 257 becomes full, the movementcontrol mechanism can be actuated to move an empty receptacle 257 underthe exposed opening 256. This movement also causes the full receptacleto move the used needles under a protective housing 295. This movementof the movement control mechanism can be manually powered or powered byany other movement device such as but not limited to: electric motors,pneumatic power, etc. The movement of the receptacles 257 can betriggered or actuated by various means including forces effected by thesame appendage as the one upon which it is being worn such as: elbow,wrist, hand, finger motion, etc.

With reference to FIG. 207, in another embodiment, the housing 295 canhave a cylindrical shape and the movement of the receptacles 257 can berotational. The housing 295 can have an opening 265 through whichneedles 104 can be inserted into the receptacles 257. When the exposedreceptacle 257 under the opening 265 is full, an empty receptacle 257can be rotated under the opening and the needles 104 can be moved to aposition completely within the housing 295.

In other embodiments, the needles 104 can be inserted into differentsurfaces of the used suture needle receptacles 257. For example, withreference to FIG. 208, in an embodiment, the receptacles 257 can move intranslation and rotation within the housing 295. Needle insertionsurfaces of the receptacles 257 can be accessible through an opening 256on the right side of the housing 295. Needles 104 can be inserted intoexposed surfaces of the receptacle 257. When the receptacle 257 is full,the system can move the receptacles to expose a surface of an emptyreceptacle 257 and the filled receptacle 257 can be moved within thehousing 295. In an embodiment, the receptacles 257 can be pressedagainst each other to fully contain inserted needles 104 and thiscontainment can prevent injury.

With reference to FIG. 209, in the illustrated embodiment a circularhousing 295 can have an opening 265 on an upper surface. Needles 104 canbe inserted into an exposed surface of a receptacle 257. When theexposed receptacle is full of needles 104, an empty receptacle 257 canbe rotated to be aligned with the opening 256 and the needles previouslyinserted into the full receptacle 257 can be rotated to be positionedcompletely within the housing 295 which can prevent the needles 104 fromcausing injury or being lost.

With reference to FIGS. 210-214 another embodiment of a used sutureneedle receptacle 257 is illustrated. In this embodiment, the usedsuture needle receptacle 257 can have a modular design with each unithaving a low profile and holding one or two needles 104. The housings295 of each used suture needle receptacle 257 can be transparent andfoam 263 can be secured to one side of the housing 295. In FIG. 210, oneneedle 104 has been inserted into the foam 263 at one end of the housing295 and in FIG. 211, two needles 104 have been inserted into the foam263.

With reference to FIG. 212, once a first receptacle 257 has been filled,a second receptacle 257 can be placed against the open side of the firstreceptacle 257 and once the second receptacle 257 is filled, a thirdreceptacle 257 can be placed against the open side of the secondreceptacle 257. The back surface of each receptacle 257 can be placedagainst the open side of the prior filled receptacle 257 and canfunction as a closing lid that contains the used needles 104 between theadjacent housings 295 so that the only exposed needles 104 are in theoutermost receptacle 257. In an embodiment illustrated in FIGS. 213 and214, the housings 295 of the adjacent receptacles 257 can be coupledwith hinges 288 that can be coupled to the foam 263 side edges of thehousings 295. When the receptacle 257 is filled, the next emptyreceptacle 257 can rotate about the hinge 288 until it is parallel andadjacent to the filled receptacle 257. This rotational motion can pressor flatten the position of the needle 104 into the space within thehousing 295 and the needle 104 can be contained by the adjacentreceptacle 257.

With reference to FIGS. 215 and 216 in another modular embodiment of aused suture needle receptacle 257 is illustrated. In this embodiment anopen sided box 260 which can have transparent walls and can be coupledto an elastic material 251 that covers the open side of the box 260.Needles 104 can be pressed through the elastic material 251 into achamber behind the elastic material 251. The elastic material 251 can bemade of sponge, foam or any other suitable elastic material that cansupport needles 104. When the maximum number of needles 104 have beeninserted into the elastic material 251 of the exposed receptacle 257, anempty receptacle 257 can be paced over the elastic material 251 of thefull receptacle 257. The bottom surface of the box 260 of the emptyreceptacle 257 can be pressing against the elastic material 251 of thefull receptacle 257. This compression can secure the needles 104 to thereceptacle 257 and allows the empty elastic material 251 to be availablefor more needles 104. With reference to FIG. 217 a plurality of adjacentreceptacles 257 are illustrated. In this example, three receptacles 257have been filled with needles 104 and needles 104 can be inserted intothe elastic material 251 of the fourth receptacle 257.

With reference to FIG. 218, an embodiment of a used suture needlereceptacle 257 is illustrated which can include a transparent dome 262,a magnetic 287 base and a needle slot 349 formed in an upper portion ofthe transparent dome 262. The needle slot 349 can match the curvature ofthe needle 104 and the needle slot 349 can have a larger cross sectionthan the needle 104. The used needles 104 can be inserted through theneedle slot 349 with a needle driver and released. The needles 104 canfall to the base of the needle receptacle 257 and magnets 287 in thebase can hold the needles 104 at the bottom of the receptacle 257.Needles 104 in the receptacle can be counted visually through thetransparent dome 262.

With reference to FIG. 219, another embodiment of a used suture needlereceptacle 257 is illustrated. The illustrated receptacle 257 caninclude a transparent dome 262, an internal foam 263 structure, a needleslot 349 and a needle driver slot 343. The needles 104 can be insertedthrough the needle slot 349 in the transparent dome 262 and the distalend of the needle driver can be inserted through the needle driver slot343. The needle driver can then press the needle 104 into thecylindrical foam 263 that can be mounted at the center axis of thetransparent dome 262. In other embodiments, the foam 263 can be anyother shape and mounted in any other suitable location within thetransparent dome 262. Once the needle 104 is secured to the foam 263,the needle driver can be removed from the transparent dome 262. In anembodiment, the foam 263 may be able to rotate relative to the needleslot 349 and a needle driver slot 343 so that needles 104 can beinserted around the entire perimeter of the cylindrical foam 263structure.

With reference to FIG. 220, an embodiment of a needle receptacle 257 isillustrated that has a circular housing 295 having an opening 256 and afoam disk 252 that can rotate within the circular housing 295. Needles104 can be inserted into portions of the foam disk 252 that are exposedthrough the opening 256. As the exposed area of the foam disk 252 arefilled with needles 104, the disk can be rotated within the housing 295to expose fresh portions of the foam disk 252. The used needles 104inserted into the foam disk 252 can be moved to positions that arecompletely surrounded by the housing 295 which can prevent the enclosedneedles 104 from causing injury. In an embodiment the housing 295 can betransparent so that the needles in the housing 295 can be easilycounted.

With reference to FIGS. 221 and 222, another embodiment of a needlereceptacle 257 can include housing 295 with an opening 256 and a spool453 upon which a roll of foam 265 is stored. With reference to FIG. 221,the foam 263 can be unrolled from the spool 453 and moved in closeproximity to the opening. Needles 104 can be inserted into the housing295 through the opening 256 and pressed into the exposed foam 263 whichcan securely hold the needles 104. When exposed area of foam 263 isfilled with needles 104, the spool 453 can rotate to move the needle 104filled foam 263 into the housing 295 and expose clean foam 263 as shownin FIG. 222. The illustrated process can continue until all of the foam263 has been unrolled from the spool 453.

Barrier

As discussed, the efficiency of suture installation processes can beimproved by placing used suture needles in a used needle receptacle or aused needle trap within the near surgical field. In an embodiment withreference to FIGS. 233 and 234, a used needle receptacle can be attachedto a barrier 403 wrapped around a forearm of a surgeon. In this example,the barrier 403 can be a layer of puncture resistant material that has acoupling mechanism on an inner surface of an end of the barrier 403. Thecoupling mechanism can be attached to the outer surface of the barrier403 so that the barrier 403 is securely wrapped around the forearm. FIG.233 illustrates a top view of the forearm with the needle receptacle 257attached to the barrier 403 adjacent to the dorsal portion of theforearm. FIG. 234 illustrates a side view of the forearm with the needlereceptacle 257 attached to the barrier 403 adjacent to the dorsalportion of the forearm and a suture pack 101 attached to the barrier 403adjacent to the volar portion of the forearm. In this configuration, asurgeon can remove a needle and suture from the suture pack 101 with aneedle driver, install the suture in the patient and place the usedneedle into the needle receptacle with out having the needle 104 leavethe near surgical field.

The barrier can function as a protective layer for a user and can bemade of various materials and can have various different shapes. Thebarrier can be worn over a limb of the user and can be made of anymaterial that can prevent needles from passing through the barrier andcontacting the covered limb of the user. With reference to FIG. 235 atop view of an embodiment of a barrier 403 is illustrated. The barrier403 can include a structural barrier layer 169 that can be made of amalleable and puncture resistant material such as aluminum. Grooves 404added to surface of the structural barrier layer 169 to control bendingalong preferential lines to facilitate conformability to a forearm of auser. The structural barrier layer 169 can be fabricated from a flatsheet of barrier material. This flat configuration of the barrier 403can be useful for storage and shipping because the barriers 403 can bestacked and a minimal volume of space is required for each barrier 403.

When the barrier 403 is used, a user can wrap the barrier around thelimb to be protected. In this example, the barrier 403 is designed toprotect a forearm. With reference to FIG. 236, the barrier 403 isillustrated after it has been bent to wrap around the forearm of a user.In this example, the grooves 404 can be substantially perpendicular tothe curvature of the bend(s). In the illustrated embodiment, a toolholder 147 is attached to the barrier 403.

With reference to FIG. 237, bottom view of an embodiment of a barrier403 is illustrated. The barrier 403 can include a structural barrierlayer 169 and an inner foam layer 171 can be attached to an innersurface of the structural barrier layer 169. The inner foam layer 171can be compressed against the limb of the user and this compression cancause the barrier 403 resist sliding against the limb.

With reference to FIG. 238, in an embodiment the barrier 403 can befabricated from a plastic material and the shape of the barrier 403 canbe formed into a generally cylindrical configuration. In the illustratedembodiment, the barrier 403 has a cylindrical forearm portion 415 thatfits around a forearm of a user. The hand portion 417 of the barrier 403can have a thumb hole 419. A thumb can be placed through the thumb hole419 to improve the securement of the barrier 403 on the forearm andprevent rotation movement of the barrier 403 around forearm.

In addition to providing protection, the barriers can also providemounting surfaces for various surgical components. With reference toFIGS. 239-241, an embodiment of a barrier 403 is shown upon which aneedle trap 331 and suture packs 101 are mounted. Various mountingmechanisms can be used to attached the needle trap 331 and suture packs101 to the outer surface of the barrier 403. In different embodiments,the mounting mechanisms for the needle trap 331 can be flat, low profilemounting interfaces which may be hook and loop, adhesive backed foamtape, a simple dovetail mount, clasps, barbed insert, pressure sensitiveadhesives or any other suitable coupling mechanism. In some embodiments,these same mounting mechanisms can be used to secure the suture packs101 to the barrier 403. However, in different mechanisms, differentmounting mechanisms can be used for the suture packs 101. For example,the suture packs 101 may be held to the barrier 403 with clips or anyother suitable mechanical devices.

With reference to FIGS. 242-244 another embodiment of a barrier 403 isillustrated. In the illustrated embodiment, the barrier can have acylindrical curvature. A thumb loop 420 can be attached to a distal endof the barrier 403 and a strap 121 can be attached to facing edges ofthe barrier 403. The user can place the barrier 403 on a forearm andplace a thumb through the thumb loop 420. The strap 121 can be anelastic structure that can provide sufficient tension to hold thebarrier 403 to the forearm. Needle receptacles 257 cam be mounted on adorsal portion of the barrier 403. In the illustrated embodiment, theneedle receptacles 257 can be positioned with the openings 256 facingtowards the user. Thus, the illustrated barrier 403 can be configured tobe worn on a user's left forearm. Clips 115 for holding suture packs canbe attached to the volar portion of the barrier 403. In the illustratedembodiment, a tool holder 147 for holding a tool 201 can be attached toa side of the barrier 403 that faces away from the user.

With reference to FIG. 249, a flat pattern for an embodiment of aforearm mounted puncture barrier 403 is illustrated. The barrier 403 canhave a distal portion that includes legs 175 that can be wrapped arounda limb of the user. The width of the barrier 403 can expand towards theproximal portion of the barrier 403. The barrier 403 material can bemade of a plastic material that is flexible but the thickness anddensity of the plastic material can be sufficient to prevent the sharpssuch as used needles, tools or other objects which have one or moresharp surfaces that can puncture the skin of the patient or surgicalstaff.

In an embodiment, the barrier 403 is needle puncture resistant,unobtrusive and conformal. The barrier 403 design and fabrication can bean optimized combination of hardness and thickness. More specifically,the barrier 403 can be hard enough to resist puncture and thin enough toremain adequately flexible to be comfortable during use. In a anembodiment, the barrier 403 can be fabricated from extruded Polyethyleneterephthalate glycol-modified (PETG) or polycarbonate which can bebetween about 0.010-0.04 inch in thickness. The hardness of the barrier403 can have a hardness between about 45A and 65D (Shore hardness scaleA and D, respectively). In an embodiment, the barrier 403 can be die cutfrom flat sheet of puncture resistant material. In another embodiment,the barrier 403 can be thermo-formed in an anatomically conformal,semi-conical shape that can be attached to the forearm and adjusted tooptimize fit with a single hand. In an alternative embodiment thebarrier 403 can be blow-molded and rotationally laser cut into thedesigned shape. In different embodiments, barriers 403 can be fabricatedusing various other manufacturing processes. In an embodiment, aconformal foam layer can be mounted on inner surface of the barrier 403.This foam forearm interface surface added to the barrier can improvecomfort. In some embodiments, the barriers 403 can be packaged in a flatform. However, in other embodiments, the barriers 403 can be packaged ina rolled up configuration. The barriers 403 can be packaged with one ormore needle traps.

With reference to FIGS. 250-252 illustrate an embodiment of a method forplacing a barrier 403 on a left forearm of a user. With reference toFIG. 250, the barrier 403 can be placed over the user's forearm and thelegs 175 can be wrapped around the user's wrist. The legs 175 aresecured around the wrist and the barrier 403 can wrap around the forearmas shown in FIG. 251. The legs 175 can be secured to each other on avolar side of the wrist as shown in FIG. 252.

With reference to FIGS. 253-256 an embodiment of the barrier 403 that isplaced over a volar side of the forearm and uses hook material 127 andloop material 129 as a coupling mechanism that used to secure thebarrier 403 to the forearm. With reference to FIG. 253, a top view ofthe outer surface of the barrier 403 is illustrated. A needle trap 331and suture pack carriers 183 that hold a suture pack 101 containingsuture needles 103 are attached to the barrier 403. In an embodiment,various mechanisms can be used to attach the needle trap 331 and/orsuture pack carriers 183 to the barrier 403. The coupling mechanisms caninclude pressure sensitive adhesive (PSA) backed hook and/or loopfasteners attached to the barrier 403 to provide mounting interfaces forthe needle trap 331, suture pack mount 183, etc.

The suture pack mounts can be integrated with or coupled to the needletrap. In different embodiments, the suture pack mounts can be positionedin two orientations. A suture pack mount 183 can be positioned above theneedle trap 331 towards the radial aspect of the forearm. In anotherembodiment, a suture pack mount 183 can be positioned under the needletrap 331 in a longitudinal configuration. In an embodiment, a die cutfoam mount can be attached to an underside of the needle trap 331 withPSA. A hook or loop fastener on an underside of the foam mount can beattached to a mating fastener on the barrier 403 to increase stabilityof a suture pack 101. Alternatively, the suture pack 101 can be attachedto the needle trap 331 by means of PSA on underside of needle entry zone333. In an embodiment, a hook or loop fastener can be attached by to thebottom of the suture pack 101 which in turn attaches to a matingfastener on the outer surface of the barrier 403.

Legs 175 or straps can extend outward from the barrier 403 at a distalportion and loop material 129 can be attached to an upper surface of oneof the legs 175. With reference to FIG. 254, a bottom view of the innersurface of the barrier 403 is illustrated. Hook material 127 can beattached to the inner surface of one of the legs 175 or straps.

With reference to FIG. 255, a top view of the carrier surface supportingthe needle trap 331 and suture pack carriers 183 on the barrier 403positioned over a volar surface of a forearm is illustrated. The legs175 can wrap around the wrist to the dorsal side of the wrist. FIG. 256illustrates a bottom view of the dorsal side of the forearm over thebarrier 403 positioned over a volar surface of a forearm is illustrated.The legs 175 can be wrapped around the wrist and the loop material 129can be coupled to the hook material 127 to secure the barrier 403 to theforearm. The overlapping distal barrier strap surfaces can enableadjustment for range of forearm sizes and fit tightness.

In other embodiments a needle receptacle 257 and/or a needle trap 331can be attached to a surgical tool 201. With reference to FIGS. 245-248an embodiment of a needle receptacle 257 and suture pack clip 115assembly 206 is illustrated. FIGS. 245 and 248 illustrate perspectiveviews of the needle receptacle 257 side of the assembly 206. The needlereceptacle 257 can include a recessed surface that can include embeddedmagnets 287 that can be surrounded by a wall 200. Needles can be placedon the magnets 287 and the magnets 287 can hold the needles 104 on therecessed surface below the outer edge of the wall 200. A suture clip 115can be mounted on the opposite side of the needle receptacle 257. Withreference to FIGS. 246 and 247 illustrate bottom perspective views ofthe needle receptacle 257 and suture pack clip 115 assembly 206. Thesuture pack clip 115 can extend inward to secure a suture pack over theback surface of the needle receptacle 257.

The needle receptacle 257 and suture pack clip 115 assembly 206 can alsoinclude a tool mounting interface 433 illustrated in FIG. 245 that caninclude a tool slot 439 and a spring 245. A proximal end of a tool canbe inserted into the tool slot 439 and the spring 245 can compress thetool slot 439 against the proximal end of the tool secure the end of thetool to the needle receptacle 257 and suture pack clip 115 assembly 206.

In other embodiments, other types of needle receptacles can be attachedto surgical tool 201. An embodiment of needle trap 331 attached to aproximal end of a surgical tool 201 is illustrated in FIGS. 257-260.FIG. 257 illustrates a perspective view of a needle trap assembly 332that includes needle traps 331 that can be coupled to a tool mountinginterface 433 that is attached to a proximal end of a surgical tool 201.FIG. 258 illustrates a front view of the needle trap assembly 332. Theneedle traps 331 in the assembly 332 can function in substantially thesame ways that the needle trap 331 described above with reference toFIG. 168. The illustrated needle trap 331 can be angled towards the leftrelative to the axis of the tool 201. When needles are inserted into theneedle trap 311 the needle insertion force can apply a rotational andtranslational force on the tool 201. With reference to FIG. 259 a sideview of the needle trap assembly 332 is illustrated. In this embodiment,the needle traps 331 can be mounted on opposite sides of the toolmounting interface 433 with the entry zones 333 of the two needle traps331 facing in opposite directions. When a needle trap 331 is being used,the needle trap assembly 332 can be rotated so that the target entryzone 333 faces the needle being inserted.

With reference to FIG. 260, an exploded view of the needle trap assembly332 is illustrated. The needle traps 331 can each include a front(upper) structure 339 and a back (lower) structure 341. Rotationalmounting components 367 can be used to attach the needle traps 331 tothe tool mounting interface 433. In the illustrated example, therotational mounting components 367 can be fastened to the holes 342 inthe lower elements 341 as well as the hole 434 extending through thetool mounting interface 433. In an embodiment, the needle traps 331 canrotate relative to the tool 201 about the holes 342 in the lowerelements 341. Once the desired angular orientation of the needle traps331 is determined, the rotational mounting components 367 can betightened to lock the needle traps 331 in the desired angularorientation. In an embodiment, the needle traps 331 can have clips onportions of the needle traps 331 that are opposite the entry zones 333.

In the illustrated embodiments, the needle traps 331 can be configuredin a back-to-back orientation. The needle traps 331 can be positioned atright angles to each other, 45 degrees off set from an axis of thesurgical tool 201. Although the tool mounting interface 433 illustratesa tool slot 439 attached to the surgical tool 201, in other embodimentsthe needle trap assembly 332 can be connected with any other types ofconnection mechanisms such as but not limited to: hook and loop, tabs,adhesives or foam etc. These various mechanisms can be used to securethe needle trap assembly 332 to various forceps geometry.

For clarity, all components of the needle traps 331 are not illustratedin FIGS. 257-260. However, in different embodiments, the needle traps331 and associated components described with reference to FIGS. 168-189can also be used with the needle trap assembly described with referenceto FIGS. 257-260, for example.

The weight of the combined needle traps and mounting structure can bewithin a range from about 5 grams to about 80 grams, for example withina range from about 10 grams to about 40 grams, for example. The weightswithin these ranges can provide balance to the surgical tool on whichone or more needle traps are placed.

The needle trap as shown in FIGS. 257 to 260 can be configured in manyways, and may be combined with a suture pack for ease of use, forexample as described with reference to FIGS. 80-84. A needle trap andsuture pack can be combined with an opposing configuration in which thesuture pack is located on an opposite side from the needle trap. Forexample, one or more of the needle traps 331 can be replaced with one ormore of the suture packages as described herein. The trap and suturepack can be mounted in an opposing configuration on the proximal end ofthe forceps, similar to the pair of needle receptacles. The weight ofthe combined needle trap and receptacle and mounting structure can bewithin a range from about 5 grams to about 80 grams, for example withina range from about 10 grams to about 40 grams, for example. The weightswithin these ranges can provide balance to the surgical tool on whichthe needle pack and traps are placed.

Alternatively, a pair of opposing suture packs can be mounted on theinstrument, and used needles stored elsewhere such as the volar forearmas described herein, and for example as described with reference toFIGS. 80-84, and which may incorporate components of the mountingassembly of FIGS. 257-260. The weight of the combined used needlereceptacles and mounting structure can be within a range from about 5grams to about 80 grams, for example within a range from about 10 gramsto about 40 grams, for example. The weights within these ranges canprovide balance to the surgical tool on which the needle packs areplaced.

Surgical Gown

In an embodiment, a surgical gown can be constructed with barrier ormultiple barriers built into the sleeves of the gown. Typically thesleeves of the gown are manufactured of lightweight fabric that isimpenetrable to fluids to protect surgeon and patient from crosscontamination. These gown materials however may not protect a surgeonfrom needle or sharps penetration or tearing. In an embodiment, thegowns can be created with barrier zones on the forearms that can beimpenetrable to needle perforation and can prevent tearing.

In an embodiment with reference to FIG. 261, a surgical gown 401 canhave a barrier 403 is created on the dorsal radial aspect region of thesurgical gown sleeve 402. The barrier 403 can have a curvilinear crosssection that can conform to the outer curvature of the forearm.

In another embodiment with reference to FIG. 262, sleeves 413 thatinclude barriers 403 can be separate components that can be placed overand can be removed from the gown 401. The sleeves 413 can have one ormore circumferential elastic elements 405 on the sleeve 413 in the areaof the barrier 403 that renders the sleeve conformal in the region ofthe zone and prevent rotation of the barrier 403 around the limb thatthe sleeve 403 is worn on. An elastic element 405 can also be placedaround the proximal edge of the sleeves 413 to hold the proximal portionof the sleeves 413 to the gown 401. Such elastic elements 405 canstabilize the sleeve 413 and the barrier 403 reducing movement anddisplacement as the surgeon moves.

In another embodiment the barrier 403 can be a flexible plastic shieldthat is substantially flat or slightly curved and conforms to the armwhen the barrier 403 is attached to the forearm over the surgical gown401. In other embodiments, additional straps and/or tabs can beadditionally used to augment the coupling of the forearm sleeve 413 tothe barrier 403 and improve the connection security. For example,Velcro, wet and dry adhesives, magnets and mechanical locks or any othersuitable types of connection mechanisms such tabs and straps can be usedto secure the sleeve 413 and barrier 403 to the user's forearm.

In an embodiment, the surgical gowns can be constructed of multiplepieces, panels and/or sheets of thermoplastic materials. These piecescan be seamlessly welded together to create the surgical gowns. Suchthermoplastics gown materials can be used to create zones of increasedmaterial thickness that can act as barrier zones. In an embodiment, thebarrier is comprised of a thickened layer and/or multiple layers of thegown material that can be thermally heated and compressed such that thematerial properties of the barrier prevent needle penetration withforces that one reasonably may anticipate in surgery.

With reference to FIGS. 263-265, side views of the barriers in gownsleeves 402 or separate sleeve 413 structures. With reference to FIG.263, a cross section of a barrier can be a thicker material 407 area ofthe sleeve, where the same surrounding gown material 411 is used tocreate a thicker more puncture resistant thicker material 407 whichfunctions as a barrier 403.

With reference to FIG. 264, in another embodiment the barrier 403 can bemade of a different material than the gown and the barrier 403 can bethermally welded 409 to the gown or sleeve material 411. For example, indifferent embodiments the barrier can be made of plastic, metal or anyother suitable barrier materials. The barrier 403 can be attached withadhesive to the gown sleeve material or can be mechanically attachedwith seams to the surrounding sleeve material. In this example, theintersecting edges of the barrier 403 material and the gown or sleevematerial 411 material are thermally welded 409 to each other. In otherembodiments with reference to FIG. 265, the barrier 403 material can bethermally welded to the outer surface of the gown or sleeve material411.

In other embodiments, the barriers 403 illustrated in FIGS. 263-265 canbe used as platforms for mounting other surgical devices such as needletraps, suture packs, tool holders and other objects. These componentscan be attached to the barriers with various types of connectionmechanisms such as: adhesives, magnetic mechanisms, mechanicalconnectors such as hook and loop materials, etc. For example, in anembodiment, a hook material can be attached to the bottom surface of aneedle trap and a loop material can be attached to an outer surface ofthe barrier 403. This configuration can allow the needle trap to bereleasably coupled to the barrier on a gown or a sleeve on the forearmof a surgeon.

In other embodiments, various mechanisms can be used to mechanicallyattach one or more suture packages to the barrier mounted on the forearmof a surgeon. With reference to FIG. 189, suture packs 101 and a needletrap 331 are illustrated mounted on the barrier. In similar embodiments,the barrier upon which the suture packs 101 and a needle trap 331 aremounted can be a barrier that is integrated with a sleeve or gown.

In different embodiments, the surgical gowns with barrier zones can bedisposable gowns or reusable fabric gowns. Alternatively, the gown canbe constructed of a disposable gown material with the barrier deviceattached to the forearm of the gown. However, after use, the barrier canbe removed from the disposable gown and reused. In these embodiments,the barrier can be attached to the sleeve with an adhesive, hook andloop coupling, or any other suitable releasable attachment components.

In an operating room, sterile sleeves 413 as illustrated in FIG. 262 canbe available to operating room personnel. If surgeon either tears orcontaminates the sleeve of a surgical gown, such an extra sleeve 413 canbe rolled onto the surgeon's arm. Such an overlay sleeve 413 preservessterility and covers any potential breach of the gown. The alternativeto the overlay sleeve 413 can be for the surgeon to “regown” which is aprocess in which the gown and multiple layers of gloves are removed, anew gown applied followed by new gloves. The overlay sleeve 413 thussaves time and is an efficient device where surgically appropriate. Asdiscussed, the overlay sleeve 413 can have a barrier 403 in the regionof the forearm. Such an overlay sleeve 413 can allow a barrier 403 to berapidly secured to operating room personnel.

Glove Extensions

In the operating room the surgeon can wear an operating gown thatextends to the wrist or palm of the surgeon. The surgeon can then placea glove or multiple layers of gloves on the fingers and hand can thenpulled proximally to cover the distal extent of the sleeve of the gown.Thus, a distal portion of the sleeve of the gown can be covered aproximal portion of the gloves.

FIGS. 286-289 illustrate different embodiments of surgical gloves 480.FIG. 286 illustrates a top view of an embodiment of a glove 480 having aglove portion 481 made of a latex type material that extends from thefingers to a middle portion of the forearm. A glove extension 483 can beattached to the proximal edge of the glove portion 481 and can extendfrom the forearm to a position that covers the elbow of the surgeon. Theglove extension 483 material can be made of surgical gown material orany other suitable material. FIG. 287 illustrates a top view of anembodiment of the glove 480 that has a glove portion 481 made of a latextype material that extends from the fingers to the wrist and a gloveextension portion 483 that extends from the wrist to a position thatcovers the elbow of the surgeon. With reference to FIG. 288, a top viewof a glove 480 having a glove portion 481 made of a latex type materialthat extends from the fingers to the wrist and a glove extension portion483 that extends from the wrist to a position that covers the elbow anda barrier 403 attached to a portion of the glove extension 383. FIG. 289illustrates a top view of a glove 480 having a glove portion thatextends from the finger to an elbow and a barrier 403 coupled to aportion of the glove portion 481. As discussed, the barriers 403 canprotect the portions of the forearm that are covered by the barriers403. In an embodiment, surgical components such as needle traps, needlereceptacles, suture pack carriers, tool holders, etc.

Embodiment of the present invention can include surgical gloves 481designed to extend proximally up the surgeon's forearm. Gloves 480 mayinclude a glove portion 481, a glove extension 483 and a barrier 403.The glove portion 481 can be fabricated with latex or latex likepolymers such as but not limited to: nitrile, isoprene, or vinyl. In anembodiment, a sleeve extension 483 can be coupled to the glove portion481 and the sleeve extension 483 can be made of a material that isdifferent than the glove portion 480 material covering the fingers. Morespecifically, the fingers of the glove 481 can be made of a differentmaterial than the rest of the glove. Such glove finger materials caninclude but are not limited to materials usually encountered in thesleeves of gown. Such materials include fabrics and thermoplasticmaterials.

In an embodiment, a glove can have a proximal extension 483 thatincludes a barrier 403 zone having a barrier material that can resistand/or prevent sharps from penetrating the barrier 403 and contactingthe flesh under the barrier 403. In an embodiment the glove barrier canalso allow any of the described components to be attached. For example,needle trap(s) and/or suture pack(s) can be attached to the glovebarrier using any of the described attachment mechanisms such as but notlimited to: adhesives, hook and loop connectors, magnets, mechanicalcouplings, etc.

In an embodiment, the glove with an integrated barrier can cover thehand and further comprise a proximal extension that extends over atleast a portion of the forearm and may possibly extend to the elbow. Theproximal extension can contain a barrier that can orient to the radialborder of the forearm. Such a barrier can also contain one or more zonesfor attachment of a needle trap(s) and/or suture pack(s).

In an embodiment, the barrier 403 on the forearm and integrated with theglove can comprise one or more devices that can function to provide abarrier 403 for the wearer of the glove 480. The barrier 403 materialintegrated with the glove 480 can be made of plastic, metal, fabric, orany other suitable material(s). In an embodiment the barrier 403 can beattached to an inside portion of the glove 480 which can be along theforearm. In another embodiment the barrier 403 sandwiches the glovebetween an inner and outer layer of the glove material.

Surgeon-Controlled Suture Cutting

Sutures are sometimes swaged into the trailing end of the needle andmust be cut at the conclusion of a stitch. A scrub technician maytraditionally cut the sutures from the needles. However, enabling thesurgeon to cut the sutures can eliminate the need for a third partyscrub technician to cut the suture. This procedural change can improveefficiency and safety. Ideally, the suture can be cut without impartingtension on the suture during the cutting.

In an embodiment with reference to FIGS. 266-268, scissors or a bladecan be worn on the surgeon's fingers like a ring. FIG. 266 illustrates afront view of a ring cutter 412 and FIG. 267 illustrates side view ofembodiments of the ring cutter 412. The ring cutter 412 can have a ring423 and a cutting blade 425 that can be oriented with the blade alignedwith the finger wearing the ring cutter 412. When a suture needs to becut, the surgeon can press the blade 425 against the suture to cut thesuture. The excess suture can be removed from the near surgical fieldand the ring cutter 412 can be used again when the next suture needs tobe cut. In other embodiments, a suture cutter may be incorporated intothe needle trap, or the barrier.

With reference to FIG. 268, an alternative embodiment of afinger-mounted blade 425 is illustrated. In this embodiment, the blade425 can be mounted on a distal portion of a rod 427 that can be coupledto multiple rings 423 that can be placed on a finger 429. The suturescan be cut by pressing the blade 425 against the sutures.

With reference to FIGS. 269-271, in an embodiment, a tool-mounted cutter437 can be permanently or removably attached to a proximal portion of atool 201 such as a forceps or needle driver. With reference to FIG. 269,the tool-mounted cutter 437 can have a tool cap 433 that has a recessthat can closely fit over the proximal portion of the tool 201. Theblade housing 435 can have two portions that extend proximally thatdefine a recessed area within the housing 435 where a blade 431 ismounted. In the illustrated embodiment, the blade 435 can have a “V”shaped cutting surface. With reference to FIGS. 270 and 271, the blade435 can be aligned with the length of the tool 201. When a suture needsto be cut, the surgeon can push the “V” shaped cutting surface againstthe suture to perform the cut.

In an embodiment with reference to FIGS. 272 and 273, a surgical tool201 can have an integrated cutter. In this example, standard blades 441can be mounted to the blade housing 445. The standard blades 441 caninclude mounting holes and the blades 441 can be secured to the blademounts 443 to rigidly secure the blades 441 to the blade housing 445. Inthis embodiment, the blades 431 can be removably attached to a proximalportion of a tool 201 which can be forceps, a needle driver or any othersurgical tool. When the blades 441 are worn and/or need to be replaced,the blades 431 can be removed from the blade mounts 443 and replaced.

With reference to FIG. 274, in an embodiment scissors can be mounted onthe end of the surgical tool 201. In this embodiment, the blade housing435 can include hinges 445 that can be living hinges that can allow theblades 431 to rotate and function as scissors for cutting sutures. Thehinges 445 can normally assume a straight shape so that when thescissors are normally open. In this embodiment, when the surgeon wantsto cut the suture, the suture can be placed between the blades 431. Thesurgeon can then squeeze to apply a compressive force to the sides ofthe housing 435 to move the blades 431 towards each other cut thesutures. When the compressive force applied to sides of the housing 435is released, the blades 431 of the scissors can separate and open.

With reference to FIGS. 275-278, an embodiment of a retractable cuttersystem 451 is illustrated. The retractable cutter system 451 can includea cutter 457 which can be a fixed blade 431. FIG. 275 illustrates a topview and FIG. 276 illustrates a side view of the retractable cuttersystem 451 in the retracted position. In the illustrate embodiment, thecutter 457 can have hinges 445 that allow the blades 431 to move andfunction as scissors 447. The cutter 457 can be coupled to an end of aretractable cable 455 that can be partially wrapped around a spool 453that can be coupled to a rotational spring 459. In a retracted position,the retractable cable 455 can be wrapped around the spool 453.

With reference to FIG. 277, the cable 455 can be pulled and the spool453 can rotate to allow the cable 45 to extend away from the spool 453.In an embodiment illustrated in FIG. 278, the retractable cutter system451 can be mounted to a barrier 403 on a forearm of the surgeon. Whenthe surgeon wants to cut a suture, the cutter 457 can be pulled from thespool 453 and press the blades 431 against the suture. When the sutureis cut, the surgeon can release the cutter 457 and the spring 459 canretract the cable 455 onto the spool 453.

In other embodiments with reference to FIGS. 279 and 280, sutures can becut with a barrier-mounted cutter 461 that can be integrated with aforearm-mounted barrier 403. FIG. 280 illustrates an enlarged view ofthe embodiment of the cutter 461. The cutter 461 can have a housing 463and a recessed blade(s) 431 on a distal portion of the housing 463. Theblade(s) 431 can be configured in a perpendicular orientation to thesurface of the barrier 403. When the surgeon needs to cut a suture, thesurgeon can pull the suture proximally to press the blade(s) 431 againstthe suture. In another embodiment, the barrier-mounted cutter 461 canfunction as scissors. In this embodiment, the housing 463 can becompressed against the barrier 403 to cause the blade(s) 431 to move andfunction as scissors. When the surgeon needs to cut a suture, thesurgeon can place the suture between the blade(s) 431 and the surgeoncan compress the housing 463 to actuate the scissors and cut the suture.

In other embodiments, the scissors can be actuated with a pneumaticpressure. In these embodiments, the scissors can be coupled through apneumatic hose to a control button which can be a valve and a pneumaticpressure source. The scissors can be normally open when the controlbutton is not actuated. For example, when the control button is pressedthe air pressure can be directed through a hose to actuate the pneumaticscissors and cut an object between the blades of the scissors. When thecontrol button is released, the air pressure can be vented and thepneumatic scissors can open the blades of the scissor.

In another embodiment with reference to FIG. 281, the blades 431 on adistal portion of scissors 447 can be mounted within a safety guard 465which can surround the sharp tips of the scissor blades 431 but alsohave a slot that can allow the suture to be positioned between theblades 431. The scissors 447 can be actuated by applying a compressiveforce which can cause the blades 431 to cut sutures in the slot 469 ofthe guard 465. In an embodiment, the scissors 447 can be actuated bycompressing opposite sides of the scissors 447. Alternatively, in otherembodiments the scissors can be actuated by other means such as but notlimited to: pneumatic foot pedal coupled to a piston, electronic signalfrom foot pedal, proximity sensing of suture within cutting zone. If thescissors 447 are actuated by pneumatic pressure, the pneumatic scissors447 could be coupled to a pressure source 475 and a control valve 477with a pneumatic hose.

With reference to FIGS. 282-285, an embodiment of a cutter 457 that canbe used to cut sutures is illustrated. FIG. 282 illustrates a side viewand FIG. 283 illustrates a top view of the cutter 457 in the openposition. FIG. 284 illustrates a side view and FIG. 285 illustrates atop view of the cutter 457 in the closed position. The cutter 457 caninclude a blade 431 coupled to a moveable piston 467 that slides withinthe guard 465. The guard 465 can have a hook or “J” shaped distal endportion that the blade 431 can contact to cut sutures placed into thecutting slot. The piston 467 can be normally retracted which moves theblade 431 away from the distal end portion and opens the cutting slotbetween the blade 431 and the inner end of the hook or “J” shaped distalportion. When the piston 467 is actuated the blade 431 can move into aclose fitting slot in the hook or “J” shaped distal end and a sutureplaced in the cutting slot can be cut. The piston 467 can be a pneumaticactuator that is actuated by applied air pressure supplied by apneumatic hose. Alternatively, the piston 467 can be an electricaldevice such as a solenoid that can use electromagnetic forces to actuatethe piston 467. In other embodiments, the piston 467 can be actuated bypure mechanical means.

In various embodiments the actuation of the described cutters andscissors can be accomplished by manually squeezing the scissors asdiscussed above, or by other means such as but not limited to: pneumaticfoot pedal coupled to a piston, electronic signal from foot pedal,proximity sensing of suture within cutting zone.

Needle Traps

Surgeons often pull the needle from the tissues after the “last throw”of the needle by grasping the tip portion of the needle. This practiceis common as the tip is the portion of the needle showing from thetissues and therefore the needle tip is the easiest portion of theneedle to grasp. The needle may not need to be regrasped (in a centerportion) after the last throw and therefore grasping of the tip of theneedle with the needle driver can provide the safety benefit of securingthe tip of the needle within the jaws of the needle driver. If theneedle driver and needle are handed to a scrub tech, the needle tip maynot be exposed and the needle handling can be less dangerous to thescrub tech and the surgeon. However, in embodiments, the used needlescan also be deposited in needle traps that can be configured to receiveneedles held by their tips by a needle driver.

With reference to FIGS. 290-294 an embodiment of a needle trap 331 isillustrated. FIG. 290 illustrates a cross sectional view and FIG. 291illustrates a front view of the needle trap 331. The illustrated needletrap 331 includes a housing 295 that is configured with a needle driverslot 343 that asymmetrically intersects one side of a needle slot 349,rather than the center of the needle slot 349. The needle slot 349 canhave compressible members 347 attached to one or both sides of theneedle slot 349. In an embodiment, the compressible members 347 can befoam. However in other embodiments, the compressible members 347 can bemade of any other suitable material. Further, the needle trap canutilize any other type of needle retention systems such as thosedescribed above with reference to FIGS. 172-179.

With reference to FIGS. 292 and 293 a tip of a needle driver 198 can beused to insert the needle 104 into the needle slot 349. The needledriver 198 can be moved to the end of the needle slot 349 and in thelocation the needle driver 198 can release the needle 104. Although theneedle driver 198 is illustrated with the tip portion held by the needledriver 198 can be substantially parallel with the needle driver slot343, in other embodiments the tip portion can be moved through theneedle driver slot 343 in any directional orientation. With reference toFIG. 294, illustrates the needle trap 331 after a plurality of needles104 have been inserted into the needle slot 349.

With reference to FIG. 295 another embodiment of a needle trap 331 isillustrated. In this embodiment the needle driver slot 343 can benarrower. The tip of the needle driver 198 can have a cross section witha width that is longer than the thickness. When the needle driver 198holds a needle 104, the tip of needle driver 198 can fit within theneedle driver slot 343. However, the needle driver slot 343 can benarrower than the width of the tip of the needle driver 198 so that theneedle driver 198 cannot freely rotate within the needle driver slot343. By forcing the needle driver 198 to assume a specific rotationalorientation, the rotational positions of the needles 104 within theneedle slot 349 can also be controlled. In an embodiment, the uniformpositions of the needles 104 can increase or optimize the number ofneedles 104 that can be stored in the needle trap 331. With reference toFIG. 295 a side view of the needle trap 331 is illustrated where theneedle driver 198 has pulled a plurality of needle 104 into the needleslot 349.

Another embodiment of a needle trap 311 is illustrated in FIG. 296. Inthis embodiment, two separate needle slots 349 can be formed in thehousing 295 with the needle slots 349 positioned on opposite sides ofthe needle driver slot 343. Compressible members 347 can be secured tothe housing 295 and adjacent to each of the needle slots 349. Theneedles 104 can be inserted into either of the needle slots 349 bysliding a needle driver 198 that is grasping a needle 104 through theneedle driver slot 343.

FIG. 297 illustrates another two needle slot 349 embodiment of theneedle trap 331. In this embodiment, the needle driver slot 343 isnarrower to that the needle driver 198 cannot rotated which can causethe needles 104 to be positioned uniformly within the needle slots 249.FIG. 298 illustrates a front view of the needle trap 331.

In another embodiment with reference to FIGS. 299-306, the needle trap311 can have a circular or spiral configuration. With reference to FIG.299, embodiments of the needle driver slot 343 can be curved in acircular or spiral shape. The needle driver slot 343 can be concentricto the needle slot 349. In the illustrated example, the needle driver198 can enter the needle driver slot 343 with a needle 104. The needledriver 198 can slide through the needle driver slot 343 and pull theneedle 104 though the needle slot 343. FIG. 300 illustrates a front viewof the needle trap 331 with the needle driver 198 in the needle driverslot 347 and the needle 104 in the needle slot 349. With reference toFIG. 301, when the needle driver 198 has moved to the end of the needledriver slot 343 where the needle 104 can be released and the needledriver 198 can be pulled away from the needle trap 331. With referenceto FIG. 302, additional needles 104 can be inserted into the needle slot343 in the described manner.

Another embodiment of a circular needle trap is illustrated withreference to FIGS. 303-306. In this embodiment, the width of the needledriver slot 343 can prevent free rotation of the needle driver 198. Theneedle driver slot 343 can be slightly wider than the width of the tipof the needle driver 198. This configuration can allow a torque to beapplied between the housing 295 and the needle driver 198 which candrive the needle driver 198 through the circular portion of the needledriver slot 343. With reference to FIG. 303, the needle driver 198 canenter the needle driver slot 343 pull the needle 104 into a straightportion of the needle slot 349. FIG. 304 illustrates a front view of theneedle trap 331. With reference to FIG. 305, once the needle driver 198reaches the curved portion of the needle driver slot 343, a torque canbe applied between the needle driver 198 and the needle trap 331. Morespecifically, a clockwise torque or rotational force can be applied tothe needle driver 198 which can be resisted by a counter clockwisetorque applied to the housing 295. The torque can cause the needledriver 198 to rotate and slide in a clockwise motion through the needledriver slot 343 which can cause the needle 104 to similarly rotate andslide within the needle slot 349. With reference to FIG. 300, once theneedle driver 198 has reached the end of the needle driver slot 343, theneedle 104 can be released and the needle 198 separated from the needletrap 331. With reference to FIG. 306, the described rotational insertionprocess can be repeated for additional needles 104 until the needle trap331 is full.

For all of the needle trap embodiments illustrated in FIGS. 290-306,entrances to the needle slots 349 and needle driver slots 343 can beflared to assist with aligning the needles 104 with the needle slots349. When the needles 104 are placed in the needle slots 349, the tipsof the needles 104 can be exposed within the needle driver slot 343,which is visible from either side of the needle trap 331. However,because a portion of the housings 295 is adjacent to the tips of theneedles 104, the needle trap 331 can prevent physical contact andinjury. The needle traps 331 can also provide grooves in the housingsadjacent to the tips of the needles 104 as illustrated in FIG. 294 andin an embodiment, the tips of the needles 104 can be placed in thesegrooves to further prevent physical contact and injury.

In the illustrated embodiments, the number of needles stored in theneedle slot 349 can be determined by counting the needles within theneedle driver slot 343. In an embodiment, some or all of the housing 295components can be made of a transparent material so that a largerportion of the trapped needles 104 can be visible. In still otherembodiments, any of the compatible needle counting systems disclosedwith reference to FIGS. 180-189 can also be used with the needle trap331 embodiments illustrated in FIGS. 290-306 to perform needle counting.

In many embodiments, the needle trap 331 embodiments illustrated inFIGS. 290-306 can be secured to platforms and barriers that can bemounted or worn on limbs of surgeons. The coupling mechanisms describedfor securing the needle traps and needle receptacles to platforms andbarriers can also be applied to the needle trap 331 embodimentsillustrated in FIGS. 290-306.

FIG. 307 illustrates an exemplary embodiment of an integrated sutureneedle dispensing and securing apparatus 308. The apparatus 308comprises a needle dispensing portion 102 and a needle receptacleportion 334, supported with the same housing 309. The housing maycomprise a single structure, such as a single molded plastic piece, orthe housing may comprise a base 310 coupled to one or more covers 312.The covers may comprise separate covers for each of the needledispensing portion 102 and the needle receptacle portion 334.Alternatively, the cover may comprise a single cover for both the needledispensing portion and the needle receptacle version. The covers, or theupper portion of the housing, can comprise an optically transparentmaterial, such that the user can easily see the number of fresh needles103 or secured needles 104 supported by the apparatus 308. The needledispensing portion 102 can be configured to support one or more freshsuture needles 103, for example via a foam member 110. The new sutureneedles 103 may be pre-loaded with sutures 155, and the sutures may bedisposed within a pocket 324 of the housing 309. The needle receptacleportion 334 can be configured to receive a plurality of suture needles104, for example using the mechanisms described herein in relation toneedle receptacle 331. In many embodiments, the apparatus 308 issterile, and can be self-supporting and/or coupled to another supportsuch as a platform or a surgical tool as described herein. Providing asingle device that integrates the functions of suture needle dispensingand securing/storage can have the advantage of providing a highlycompact system for suture needle handling.

FIG. 308 is a block diagram of a sterile suturing kit 500 in accordancewith embodiments. The sterile suturing kit 500 comprises a sterileenclosure 505 containing a sterile package 101 of sterile sutures 103,and a sterile apparatus 331 for receiving at least one contaminatedsurgical suture needle 104. The sterile apparatus 331 may comprise anyneedle receptacle or sharps container as described herein, for example.The sterile needle receptacle 331 comprises a sterile housing 340 havinga top and a bottom. The needle receptacle 331 further comprises at leastone opening 350 between the top and the bottom of the housing 340,configured and dimensioned to receive a contaminated surgical needle 104inserted through the opening. The needle receptacle 331 furthercomprises a secure zone 337 within the housing, to hold the contaminatedsurgical needle 104 in a predetermined orientation with the needle tipsecured. The sterile surgical kit 500 may further comprise a protectivebarrier as described herein, configured and dimensioned to support thesterile suture package 101 and sterile needle receptacle 331. Thebarrier may, for example, be configured to be mounted to a forearm of asurgeon, as described herein.

The materials and structures to stabilize needles as described hereincan be configured in many ways. The materials and structures maycomprise one or more one or more of a deformable material, an adhesivematerial or an elastic material, and the material may comprise one ormore of a foam, elastic membrane, or an adhesive, for example.

In many embodiments, a needle resistant barrier as described herein cancomprise a thin, puncture-resistant material integrated with a flexibleweb. The barrier can comprise a plurality of bi-stable springs connectedby a flexible, in order to accommodate a range of different forearmsizes. The plurality of bi-stable springs can comprise a plurality ofstacked bi-stable springs, to adjust a compressive force.

Although the suture handling systems and methods as described herein arepresented in the context of a surgeon closing a patient's wound, thesystems and methods can be used in any situation involving the handlingof suture needles. For example, the systems and methods may be used tosafely dispense and dispose of suture needles when the dispensed sutureneedle is not used to install a suture in a patient. For example, asurgeon may dispense a fresh suture needle, and then decide that he doesnot want to use the dispensed needle. The surgeon may decide that aneedle of a different size would be more appropriate, or that thedispensed needle is not needed after all, for example. The surgeon mayaccidentally contaminate a freshly dispensed needle before the needle isused (e.g., by touching the tip of the fresh needle against an unsterilesurface), and may therefore have to dispose of the needle without usingit. A need to attend to another matter may arise after the surgeon hasalready dispensed a fresh suture needle (e.g., blood splashed onsurgeon's gloves necessitating a change of gloves), necessitating thedisposal of the fresh needle before it can be used.

As used herein the terms “needle trap” and “needle receptacle” are usedinterchangeably.

As used herein the terms “shell” and “shell structure” are usedinterchangeably.

As used herein the terms “panel” and “shell” are used interchangeably.

The present inventors have conducted several experimental studies todetermine needle receptacles and barriers that work well in the surgicalenvironment. Several prototypes have been built and tested, andperformance metrics measured.

In many instances the needle receptacle is referred to with reference tothe receptacle as placed on the volar forearm of the user such as asurgeon. In this regard, the term “distal” may refer to the opening ofthe needle receptacle that receives the needle from outside thereceptacle, and the term “proximal” may refer to the secure zone intowhich the needle is placed after moving through the distal opening.

The needle receptacle may comprise a front (upper) and back (lower)panel that houses the needles with a secure zone. The needle receptaclemay comprise a planar needle slot or groove along which needles areconveyed and within which the needles are housed, partially encased in aparallel, back to back, single layer array, for example. A needle driverslot in the back (lower) panel allows the needle and needle driver tobecome aligned with the needle slot. The back (lower) needle driver slotcan be located distally to the needle slot with an enlarged opening,such that the needle driver can be aligned with the needle slot prior toentry into the needle slot. The experiments of the present inventorshave suggested that a back panel landing zone and needle slot havingsubstantially planar configurations may be preferred. For example, theneedle slot can be substantially parallel (e.g. generally within aboutten degrees) with the front surface of the landing zone, for examplecoplanar. The inventors have tested a trumpet or funnel shaped landingzone having a tapered concave section, and these experiments indicatedthat a planar landing zone may provide improved performance. The landingzone can have a distance transverse to the longitudinal axis thatdefines the width of the landing zone. The maximum distance across ofthe width of the landing zone can be within a range from about 20 mm toabout 60 mm, for example within a range from about 30 mm to about 50 mm.The width of landing zone can taper from the maximum distance to alesser distance near the needle entry slot, for example adjacent theneedle entry slot. The distance across the landing zone near the needleentry slot can be within a range from about 20 mm to about 60 mm, forexample within a range from about 20 mm to about 50 mm.

The entry zone of the needle slot can be sized larger than the securezone of the needle slot. As described herein, the elongate needlechannel slot may comprise a first elongate width CW1 near an opening ofthe needle slot 349, and a second narrower width CW2 within the securezone of the needle slot. The height of the needle slot above the landingzone can be within a range from about 4-10 mm, for example from about5-8 mm. The width CW1 can be within a range from about 20 to about 60mm, for example from about 30 mm to about 50 mm. The entry zone of intothe needle receptacle may comprise an upward flare near the edges toprovide sufficient clearance for the needle. The upward flare canprovide height to the distal opening of the needle slot. The flare canbe within a range from about 50 degrees to about 90 degrees relative tothe surface of the landing zone. For example, within a range from about60 degrees to about 80 degrees.

The needle driver slot width is designed to be sufficient to accommodatea needle driver various orientations. The needle driver slot depth ofthe lower slot is dimensioned to allow protrusion of the needle driverjaws when the needle driver grasps the needle away from the ends.

In accordance with these experiments and contemplated embodiments, thelanding zone front face may be substantially planar, and needle slot ofthe secure zone substantially planar, for example substantially parallelto each other. In some embodiments, the landing zone and needle slot canbe substantially parallel with each other. In many embodiments, a planedefined by the landing zone extends through the secure zone of theneedle receptacle.

The needle receptacle can suspend the needle/s while protecting the tipand tail end of the needle in a stiff protective container, for examplea hard container. The landing zone and secure zone can be arranged toguide the needle and provide tactile feedback to the user.

The needle receptacle may maintain needles along a plane and providesthe suspension of the needles such that tip and ends are between theprotective stiff cover in front and stiff cover in back, for examplehard cover in front and hard cover in back. This can suspend the middleof the needle in air. This configuration allows for counting and allowsfor access to manipulate and position the needles for counting by visualassessment. The planar orientation can be orthogonal to a user's line ofsight when counting and can display the needle in full profile for easyvisual assessment. Other planar organization may comprise a needlemagnet or a flat adhesive strip, although these do allow for access tothe needle, the needle may not be grasp and manipulated as easily.

The thickness of that needle slot in which the needle is housed can bedimensioned appropriately. If the needle slot is too wide, the needlecould rotate/twist or come loose. The present inventors have made alimited needle slot groove width between the hard plastic shells andthen further reduced this space by using foam compression, which alsoprovides friction component. The arc of the needle can facilitatecapture, although straight needles can also be captured. In manyembodiments, the needle tip and end are secured within planar recessessuch as grooves. Other structures are contemplated and described hereinthat allow for the suspension or “floating” of the mid portion of theneedle, for example in air.

In many embodiments, a slotted structure is configured to allow the tipand tail of the needle to be substantially enclosed while suspending inthe slot the mid portion of the needle.

A needle could be contained in the planar recess (Groove) on one endonly with the needle tip for instance residing in the longitudinal slotas described herein. The needle tip can be recessed from the frontalsurface of the receptacle to provide improved safety.

The lower trap slot can be configured with depth to accommodate the tipof the needle driver that may well extend beyond the needle slot plane.The lower or back slot may comprise a groove of sufficient depth toallow the needle driver to advance the needle along the slot.

The present inventors have conducted experiments to determine suitableamounts of force to advance the needle along the slot or other structureto secure the needle. Structures can be provided to provide a greateramount of force to remove the needle than insert the needle.

While the thickness profile of the needle receptacle can be configuredin many ways, the thickness can be less than 2 cm in preferredembodiments, in which the needle receptacle comprises a longitudinallength and a cross-sectional width dimensioned greater than thethickness. The thickness profile can be especially helpful on the volarside of the forearm and other surfaces on the forearm as well. Theneedle retention device may have a profile above the surface of thebarrier of less than 4 cm, for example. The profile can be furtherreduced by creating a recess in the barrier to accommodate the trap. Acutout can be provided in the barrier, in which the footprint of thecutout corresponds to the trap. Alternatively or in combination when thetrap has a solid back wall to the slot and the trap fit with thebarrier, the trap can be recessed. The recess may comprise a depth 2 to5 mm, for example.

The barrier may comprise the receptacle as described herein in order todecrease the profile.

The trap can be configured to facilitate safe handling or transferbetween personnel in many ways. The needle landing zone can be used tograsp the needle receptacle. The needle receptacle can be held up to alight source, such that the needles are not obscured by the fingers orhand of the user. The needle receptacle may comprise a material or dyehaving an orange color, red or other color, for example. The backlightillumination can highlight the profile of the needle when needlevisualized through the front face, which can be transparent. Thewell-defined profile can be helpful for counting, for example by aperson or an automated needle counter, such as a video camera coupled toa processor with appropriate software. Any needle receptacle asdisclosed herein can be configured with a landing zone that can be usedfor dual purpose of safe handling and needle placement.

FIG. 309 shows a suture pack 3092 and needle receptacle 3094 coupled toa barrier mounting base 3096. The barrier mounting base comprises aliving hinge 3098. A suture pack and a needle receptacle are coupled tothe barrier mounting base. The barrier mounting base comprises theliving hinge in order to allow the suture pack and needle receptacle tofit onto the barrier on the arm of the surgeon with an angle between afirst portion 3096 a of the barrier mounting base having the needlereceptacle and a second portion 3096 b of the barrier mounting basehaving the suture pack. The first portion of the barrier mounting baseand the second portion of the barrier mounting base can be placed on thearm with the living hinge such that they are inclined at an angle withrespect to each other. The suture pack and needle receptacle shown withreference to FIG. 309 may comprise many of the structures shown withreference to FIGS. 167 to 179, and a person of ordinary skill in the artwill recognize that many of these embodiments are well suited forcombination with each other, as well as other embodiments as shown anddescribed herein.

The needle receptacle can be configured with various amounts ofresistance in many ways. In many instances, the needle receptaclecomprises an amount of force for insertion of the needle and a greateramount of force to remove the needle. The needle receptacle comprises astructure to receive a needle with resistance. The amount of resistanceto insertion can be within a range from about 5 grams to 250 grams, forexample. The amount of force can be within one or more of the followingranges: about 25 grams to about 100 grams; or about 30 grams to about 90grams, for example. The needle receptacle may comprise a needle slot,and the amount of force may comprise an amount of force to advance theneedle along the needle slot. Alternatively or in combination, theneedle receptacle may comprise a needle driver slot, and the amount offorce may comprise an amount of force to advance the needle driver alongthe needle driver slot to secure the needle in the needle slot.

The needle receptacle may be configured to provide an increasing amountof resistance as the needle is advanced along the needle slot. Thevarying resistance is provided with one or more of a discrete orasymmetric features that protrude into the needle slot, in order toincrease compression of the needle and provide tactile feedback as theneedle is drawn along the slot.

The needle receptacle may comprise a compressive member configured tosecure a needle and provide resistance to movement of the needle againstan apposed surface, and wherein the foam structure comprises a gap ofless than 2 mm between the foam and the apposed surface.

The needle receptacle comprises a secure zone and can be applied to theforearm and comprises a width of less than 12 cm, and a length of lessthan 26 cm. The appropriately sized receptacle can be applied to theforearm or a barrier as described herein.

The needle receptacle can also be configured to easily view the needleswith various types of illumination. For example, the housing containingthe needles may comprise an optically transmissive material. A lowerportion of the housing may comprises an optically transmissive materialin order to view needles within a secure zone of the receptacle withbacklight illumination. Alternatively or in combination, the upperportion may comprise a transparent material to view the needles. Thelower portion may comprise a transparent or a translucent material topass backlight illumination light to the needles. The upper portion maycomprise the upper shell, and the lower portion may comprise the lowershell as described herein, for example.

The needle receptacle trap may comprise a landing zone and a securezone, in which the landing zone is substantially coplanar with thesecure zone. The landing zone coplanar with the secure zone can make iteasier for a user to place the needles in the trap. The needle can beplaced by moving the needle to the landing zone of the needle receptacleand sliding the needle from the landing zone into the secure zone of theneedle receptacle.

The needle receptacle may comprise a slotted structure that allows a tipand a tail of the needle to be substantially enclosed while suspending amid-portion of the needle in the slot.

The needle receptacle may comprise a slot along a secure zone, in whichthe slot is sized smaller than a finger tip having a size of about 10mm.

A needle receptacle comprising a needle groove having a thickness smallenough to inhibit rotational movement of the needle out of the needlegroove.

FIG. 310 shows the needle receptacle as in FIG. 309. FIG. 310 shows atop oblique view of the needle receptacle in a fully assembledconfiguration. The needle receptacle 3094 is configured to define thedirection in which needles are moved to place the needles in thereceptacle. The needle receptacle comprises an arrow tip 3101 a and anarrow tail 3101 b. The arrow tip comprises a generally convexly curvedtip in order to define one direction of movement, and the arrow tailcomprises a generally concave profile to define the direction of motion.The needle receptacle comprises a top needle driver groove 3102 aconfigured to receive a needle driver holding a needle. The needlereceptacle comprises an entry zone 3103 configured for landing of theneedle as the surgeon places the needle into the receptacle. The entryzone is sized and shaped to allow the surgeon to place the needle on theentry zone, or land the needle with an arcuate movement of the needle inthe needle driver. As the surgeon rotates his or her arm, the needledriver extends with an arcuate motion onto the landing zone and into asecure zone 3104 of the needle trap. The needle trap or receptaclecomprises the top needle driver groove 3102 a and a bottom needle drivergroove 3102 b to allow the needle driver to be advanced while the needleenters the secure zone. An elevated flange 3105 extends above the entryzone to receive the needle. The elevated zone defines an entry openingsized larger than the secure zone. The elevated flange guides the needlefrom the entry zone into the secure zone. The needle receptaclecomprises inner protrusions 3106 that engage the needle as the needle isslid along the secure zone toward a needle stop 3107 on a distal end ofthe receptacle. The needle stop is configured to limit movement of theneedle within the secure zone to a most distal portion of the needlereceptacle. The inner protrusions may comprise feedback to the user withtactile sensation of the needle with a clicking-type sensation as theneedle is drawn into the secure zone to give the user feedback as to thedepth of placement into the needle receptacle. Alternatively or incombination, the top needle driver groove and/or the bottom needledriver groove may comprise undulating structures that allow the user tohave feedback as the needle driver is advanced along the slot toward theend of the needle secure zone. As the needle driver is drawn along theneedle driver grooves and slots, the user is provided feedback byundulation from one side or the other side or both of the needle drivergrooves. The lower needle driver slot 3102 b comprises an enlargedopening within the landing zone or entry zone, such that the needledriver can be received into the lower needle driver slot as the needleis advanced in the lower needle driver slot comprises a smallercross-section in the secure zone than in the entry zone. The entry zoneof the needle receptacle comprises a bevel 3108 near the arrow tail. Thebevel zone facilitates landing of the needle into the entry zone.

The needle receptacle may comprise an upper shell structure and a lowershell structure. The upper shell structure may comprise the top needledriver groove and the undulations in the elevated flange, the needlestop, and a portion of the arrow tip. The lower portion may comprise theentry zone, the lower needle driver slot, the arrow tail, and the bevel.The upper shell structure and the lower shell structure may comprisecoupling structures 3109 to couple the upper shell structure with thelower shell structure.

The needle receptacle can be placed on the volar forearm of the user ona barrier as described herein. The needle receptacle can be arrangedover the volar forearm to allow easy insertion of a used needle when ahand holding needle holder is slightly supinated or slightly pronated.The needle can be placed in the receptacle with rotation of an armholding a needle driver with shoulder joint rotation in order to alignand place the used needle into an opening of the needle receptacle, forexample.

While the needle receptacle can be dimensioned in many ways, the needlereceptacle may comprises a longitudinal length, a transverse width and aheight. The length may be greater than the width and the height, and thewidth is greater than the height. The length can be within a range fromabout 4 cm to about 15 cm, the width is within a range from about 3 cmto about 6 cm, and the height is within a range from about 0.5 cm toabout 2 cm, for example. The needle receptacle may comprise an openingto receive the needle, and the opening can be sized larger than thesecure zone of the receptacle, such that the opening comprises themaximum height and width of the receptacle.

FIG. 311 shows a top exploded view of the needle receptacle 3094 withneedles 3111 coupled to the barrier mounting base 3096. As in FIG. 310,the exploded view shows the top shell structure 3112, needles 3111, acompressive member 3113, a bottom shell structure 3114, an adhesivebacking 3115, a barrier mounting base 3096, a living hinge 3098, asuture pack adhesive 3116, and a mounting base adhesive 3117. Thecompressive member 3113 fits into a recess in the bottom shell structure3114, and the compressive member may comprise a plurality of compressivemembers fitting into a plurality of recesses in the bottom shellstructure. The compressive member is shown as a first compressive memberand a second compressive member disposed on either sides of the needledriver slot. The compressive members urge the needle upward toward thetop shell structure, such that the needle engages the top shell in theprotrusions of the top shell structure. The compressive member is shownwith a generally rounded end near the landing zone or receptacle zone ofthe bottom shell structure. This rounding of the compressive member orbevel or fillet can facilitate advancement of the needle into the securezone. The adhesive backing 3115 can be used to couple the bottom shellstructure to the barrier mounting base. The adhesive backing maycomprise an adhesive on each side of the adhesive backing. The adhesivebacking may comprise a plurality of adhesive backings, such as a firstadhesive backing and a second adhesive backing disposed on either sideof the lower needle driver slot. The bottom shell structure may comprisestandoffs on the lower surface, as shown and described in figures hereinelsewhere. The adhesive backing positions the bottom shell structure ata distance up above the barrier mounting base, with standoffs on thebottom shell structure to provide the lower needle driver slotsufficient room and depth to receive a needle in the needle driver whenthe needle is located away from the distal end of the needle driver. Thebarrier mounting base may comprise a suture pack adhesive 3116. Thelower surface of the mounting base may comprise a mounting base adhesive3117. The barrier mounting base may comprise a first portion 3096 ahaving the needle receptacle placed thereon, and a second portion 3096 bhaving the suture pack adhesive placed thereon, with a living hinge 3098extending there between. The living hinge allows the first portion andthe second portion to be inclined relative to each other when placed onthe protective barrier on the forearm of the user.

FIG. 312 shows a bottom exploded view of the needle receptacle 3094 withneedles 3111 coupled to the barrier mounting base 3096 as in FIGS. 310and 311. The top shell structure 3112 of the needle receptacle comprisesinner protrusions 3121. The inner protrusions may comprise asymmetricprotrusions. For example, the asymmetric protrusions can be shaped suchthat a needle is more readily advanced into the needle receptacle thandrawn from the secure zone of the needle receptacle. The innerprotrusions can be sized and shaped in many ways, and may comprise, forexample, a ratcheting mechanism one engaged with the needle. The needlesengage the compressive member 3113 as the needles are advanced along thereceptacle, such that the needles are urged upwards by the compressivemembers into the inner protrusions. The bottom shell structure 3114comprises a standout to receive the compressive members and to definethe needle driver groove and also to define a recess in which thecompressive members are located in the entry zone with the tips of thecompressive members deflected downward such that the compressive membersdo not provide a gap extending upwardly from the entry zone so that theneedles can advance smoothly onto the compressive members. The standoutmay comprise a standout 3122 a to receive a compressive member and thestandout 3122 b for the lower needle drive groove. The upper and lowerneedle driver grooves extend generally along an elongate axis of theneedle receptacle. The standout to receive the compressive memberextends generally transverse, for example, perpendicular to the longaxis of the needle receptacle. The adhesive backing 3115 is showndisposed on either side of the standout 3122 b for the lower needledriver groove. The adhesive backing may comprise a first portion and asecond portion, such as a first piece and a second piece. The adhesivebacking may comprise a cutout sized and shaped to receive the standoutfor the compressive member. The barrier mounting base 3096 is shownbeneath the adhesive backing that supports the needle receptacle. Thebarrier mounting base comprises a first portion 3096 a supporting theneedle receptacle and a second portion 3096 b to support the suturepack. The first portion of the barrier mounting base may comprise aplurality of adhesive pads 3123 a to support the first portion of thebarrier mounting base, and the second portion of the barrier mountingbase may comprise a plurality of adhesive pads 3123 b. The adhesive padsmay comprise a first surface having an adhesive and a second oppositesurface having an adhesive. The living hinge 3098 extends between thefirst portion of the barrier mounting base and the second portion of thebarrier mounting base, to allow the first portion of the barriermounting base and the second portion of the barrier mounting base to bemounted on the protective barrier on the arm at an angle to each other.

FIG. 313 shows a top oblique view of the top shell structure 3112 of theneedle receptacle as in FIG. 312. The top shell structure may comprisecomponents as described herein. The top shell structure comprises theupper needle driver groove 3102 a and the inner protrusions 3106 and theneedle stop 3107 as described herein. The needle protrusions generallyface downward as shown in the other views. The upper flange 3105 isshaped to direct the needle driver with the needle toward the needledriver slot or groove on the upper shell structure. The upper flangecomprises a first side 3105 a and a second side 3105 b disposed onopposite sides of the upper needle driver slot. The landing zone end ofthe first side and second side of the upper flange are inclined at anangle so as to guide the needle driver into the needle driver slot.

FIG. 314 shows a bottom oblique view of the top shell 3112 as in FIG.313. The top shell structure 3112 comprises the upper needle drivergroove 3102 a and the inner protrusions 3106 along the lower surface ofthe upper needle driver slot. The top shell structure also comprises theneedle stops 3107 on the lower surface of the top shell structure. Theplurality of needle stops is shown on either side of the upper needledriver slot. The inner protrusions are shown symmetrically disposed oneach side of the upper needle driver groove. The top shell structurecomprises an edge 3141 shaped to engage the bottom shell structure.

FIG. 315 shows a close-up bottom oblique view of the top shell 3112 asin FIG. 314. The plurality of needle stops 3107 are shown symmetricallydisposed on either side of the top needle driver slot 3102 a. The innerprotrusions 3106 are shown symmetrically disposed on either side of theupper needle driver slot. The inner protrusions may comprise asymmetricprotrusions. The inner protrusions can be sized and shaped in many ways.For example, the inner protrusions may comprise a ramp with an inclinedsurface to allow the needle to be advanced toward the needle stop. Asecond opposite surface of each protrusion may comprise a verticallyinclined surface to inhibit movement of the needle away from the needlestop.

FIG. 316 shows a top oblique view of the bottom shell structure 3114 ofthe needle receptacle as in FIG. 310. The lower needle driver slot orgroove 3102 b comprises a receiving portion 3161 located within theentry zone 3103. The needle driver slot within the entry zone comprisesa cross-sectional dimension sized larger than the lower needle driverslot in the secure zone, in order to facilitate and guide the needledriver into the secure zone. The bottom shell structure comprisesfilleted recesses 3162 to receive the compressive member. The recessesare dimensioned to urge the needle into the protrusions with thecompressive member. The recesses comprise a filleted zone 3163 near theentry zone. The bevel 3108 of the entry zone allows the needle driver tobe guided into the needle receptacle. The bottom shell may comprise araised edge or protrusion 3164 configured to engage the top shellstructure to facilitate coupling of the top and bottom shells.

FIG. 317 shows a bottom oblique view of the bottom shell structure 3114as in FIG. 316. The lower needle driver slot 3102 b is shown extendingalong a long axis of the needle receptacle. Protruding standouts 3122 afor the filleted recesses are shown extending transverse, for exampleperpendicular to the long axis of the needle receptacle. Standouts 3122b for the lower needle driver groove are shown extending along the longaxis defined with the needle driver slot. The standouts extend adistance from the surface of the bottom shell structure in order todimension the lower needle driver slot in the fillets of the recess thatreceives the compressive member. The standouts for the lower needledriver slot are dimensioned to allow the needle driver sufficientclearance to advance easily along the lower needle driver slot when theneedle has been engaged away from the proximal end of the needle driver.The standouts for the filleted recesses extend a distance from the lowersurface of the bottom shelf in order for the compressive members to beflush with the entry zone or beneath the entry zone along the uppersurface of the compressive member. This configuration of the standoutfor the filleted recess and the compressive member allows thecompressive member to gradually urge the needle upward into the uppershell structure as the needle is advanced toward the stops on theproximal end of the needle receptacle. The standouts for the filletedrecesses are symmetrically disposed on either side of the lower needledriver slot. The standouts for the lower needle driver groove aresymmetrically arranged on either side of the lower needle driver slot.The standouts for the lower needle driver groove may extend across themidline of the bottom shell structure. The standout for the lower needledriver groove may comprise a curved surface on either end defining theends of the lower needle driver slot. The standout for the lower needledriver groove may comprise a single standout or plurality of standoutsarranged to position in dimension the lower needle driver slot to allowthe needle driver to be advanced along the lower needle driver slot whenthe suture is positioned away from the proximal end of the needle.

FIG. 318 shows a top oblique view of the bottom shell structure 3114 asin FIG. 317 with compressive members 3113 placed thereon. Thecompressive members are shown disposed on either side of the lowerneedle driver slot 3102 b. The compressive members can be symmetricallydisposed on either side of the lower needle driver slot. The compressivemembers comprise filleted or beveled ends 3181 that extend down into therecess of the lower shell structure. The upper surfaces of thecompressive members extend down to the height of the entry zone suchthat the proximal most ends of the compressive members are the heightbelow the entry zone or flush with the entry zone in order to facilitatemovement of the needles toward the needle stop on the proximal end ofthe receptacle. The inner surfaces 3182 of the compressive memberstowards the needle driver slot are approximately flush with the needledriver slot. This positioning of the inner surfaces of the compressivemembers allows the compressive members to engage the needle in theneedle receptacle when the needle extends only a little bit into thereceptacle from the slot. The inner surfaces of the compressive membersare generally positioned within about 2 millimeters, for example, withinabout 1 millimeter of the lower needle driver slot of the bottom shellstructure. This arrangement of the inner surfaces of the compressivemembers insures that the compressive members engage the needle whenadvanced into the secure zone.

The compressive members are dimensioned to allow the needle to bereadily advanced into the secure zone with decreased amounts ofresistance. In this regard the cross-sectional dimensions of thecompressive members are sized to provide appropriate amounts ofresistance. For example, the compressive members may not extend fullyoutward toward the full width of the bottom shell structure. Thecompressive members comprise a generally cross-sectional shape having arectangle. The rectangular shape of the cross-section may comprise aheight and a width from with the height is dimensioned to urge theneedle upward toward the upper shell structure and the width dimensionedwith the cross-section to provide appropriate amounts of resistance. Thewider the compressive member the greater the amount of force to theneedle. The narrower the compressive member the less the force.

FIG. 319 shows a longitudinal cross-sectional view of the top and bottomshell structure as in FIG. 310 without the compressive members. Theasymmetric inter-protrusions 3106 are shown on the top shell structure3112. Although these protrusions are shown as asymmetric the protrusionscan be symmetrical, for example defined with bumps such as sphericalsurfaces. The inter-protrusions are shown with an inclined surface thatengages the needle as the needle is advanced toward the stop and avertically extending surface or substantially vertically extendingsurface on the proximal side of the protrusion to inhibit movement ofthe needle away from the stop. The filleted recess 3162 to receive thecompressive member is shown with a curved surface extending downwardtoward the lower surface of the bottom shell structure 3114. Thefilleted recess alternatively may comprise a bevel or plurality ofsegmented linear surfaces. The recess extends downwardly away from theupper shell structure to receive the compressive member as describeherein.

FIG. 320 shows the fully assembled needle receptacle 3094 with theneedle 3111 in a transverse cross-sectional view for the needlereceptacle as shown in FIG. 310. The needle 3111 is shown positionedbetween the upper shell structure 3112 and the lower shell structure3114. The trailing end 3111 a of the needle after the suture has beenpopped off is also shown. The top shell structure is shown coupled tothe bottom shell structure and can be adhered to the bottom shell withadhesive. The top shell and the bottom shell comprise engagementstructures 3109 for the top shell to engage the bottom shell with theadhesive. The engagement structures may comprise grooves or protrusionson the top shell and bottom shell such that the bottom shell and the topshell are easily positioned together with the adhesive.

FIG. 321 shows advancement of the needle 3111 positioned into the needlereceptacle 3094 as in FIG. 310. The needle is shown to advance into theneedle receptacle with a movement that is approximately parallel to thebarrier in the user as shown with the arrow 3212.

FIG. 322A shows a top oblique view and FIG. 322B shows a cross-sectionalview of the needle 3111 stabilized in the needle receptacle 3094. Thelower slot 3102 b is shown and the upper slot 3102 a is shown with theneedle positioned between the upper shell 3112 and the lower shell 3114.The needle stabilizer 3221 may comprise the compressive members and/orthe protrusions as described herein.

FIG. 323 shows dimensions of the needle receptacle 3094 as in FIG. 310.The needle receptacle comprises a cross-sectional dimension of theneedle driver slot that is shown with dimension A. The user has a fingerwith the dimension across as shown with dimension B. The dimensionacross the slot is less than the dimension of the finger of the user.For example, the user may have a typical finger size greater than 10millimeters across and the dimension of the slot receiving the needledriver on the upper shell may be less than 10 millimeters for example.The landing zone or entry zone of the needle receptacle is generallydimensioned so that the user can easily grasp the needle receptacle witha finger as shown in FIG. 323 away from the area where the needles aresecurely stored. The entry or landing zone may comprise a flange portionof the lower shell which allows the user to grasp and handle the needlereceptacle safely.

FIGS. 324A and 324B show a needle containment groove 3241 defined with aU-shaped housing 3242 having a slot to secure needles, which maycomprise some of the structures shown in FIG. 310, such as the needledriver slot 3243 to receive needles on upper and lower portions of thehousing. Alternatively or in combination, the housing may comprise asingle-piece housing formed of materials such as silicone. The needlecontainment groove 3241 is dimensioned to receive the needle and theneedle driver slot 3243 is dimensioned to receive the needle driver onthe upper and lower surfaces. The needle receptacle 3240 comprises thelength extending along the needle driver slot and a width extendingtransverse to the needle driver slot. The needle receptacle alsocomprises a thickness 3244 as shown in FIG. 324B. The thickness isgenerally less than about 1 centimeter. The needle receptacle maycomprise a U-shaped piece for example. The needle slot may defined withinner grooves on legs of the U-shaped piece, and the grooves maycomprise a thickness of no more than about 1 cm, for example. The needledriver slot can be no more than about 2 cm, for example.

The receptacle can be sized to a range of needles, and may comprise asmaller slot for smaller needle drivers, in which the slot comprises awidth of no more than a diameter of a largest needle for which the trapis designed to store.

The longitudinal slot for the needle driver may comprise a through andthrough slot, in which the slot extends though both sides of thereceptacle.

The longitudinal slot may comprise a lower solid wall, in which the wallhas a recess or groove of sufficient depth to allow the tip of theneedle driver to protrude beyond the needle securement slot plane, inwhich the needle driver groove or slot extends beneath the needle slotplane by a distance within a range from about 0.1 mm to about 10 mm.

The receptacle may comprise a longitudinal slot bounded by a structureto one or more sides of the slot that creates a varying resistance totranslation as the needle is drawn along the slot. The varyingresistance can be provided in many ways, and may comprise a discrete orasymmetric features that protrude into the needle slot, in order toincrease compression of the needle and provide tactile feedback as theneedle is drawn along the slot

FIGS. 325A-325C show needles placed in a needle receptacle 3240 as inFIG. 324A. FIG. 325A is a top view, FIG. 325B is an end view, and FIG.325C is a side cross-sectional view of the needle receptacle 3240holding the needles 3251. The needles are shown extending at variouslocations across the needle driver slot 3243. The grooved sides 3252 ofthe needle receptacle safely contain the needles and cover the tips. Theupper view of FIG. 325A shows the needles visible to the user. Theneedles are shown extending across the needle driver slots such that theneedles can be counted. The end view of FIG. 325B shows the groovedsides 3252 containing the tips of the needles. The side cross-sectionalview of FIG. 325C shows the needles placed in the needle receptacle.

FIGS. 326A-326D show needles placed in a needle receptacle as describedherein, for example, with reference to FIGS. 310 and 324. FIG. 326Ashows an oblique view, FIG. 326B a side view, FIG. 326C a top view, andFIG. 326D an end view. The needles 3261 are shown contained within agroove 3262 of the needle receptacle. The needle receptacle may comprisewalls 3263 such as the upper and lower surfaces of the shells asdescribed herein. The needles are contained between the walls in asecured configuration such that the needle tips are covered. The needlesare shown in a planer array arranged in a groove. The longitudinal slotof the receptacle facilitates an organized deposition of the needles inthe secure zone between walls of the needle receptacle.

FIG. 327A shows ratcheting 3271 along the groove of the needle driverslot 3272 for example with reference to FIGS. 310 and 324. The ratchetedslot 3272 allows the user to sense the depth at which the needles arebeing placed along the needle driver slot. The needle driver slot maycontain many types of protrusions or undulations along the side of theslot to provide the user with tactile feedback and sensation as theneedle driver is advanced toward the stop on the proximal end. Thisfeedback to the user allows the user to position the needles with grossmotor skills and to provide a sense of the depth of the needle withinthe slot. The ratcheted slot may comprise a defined surface such thatthe needle driver is more easily advanced toward the end of the slot andaway from the end of the slot. Although the needle driver slot may bedimensioned larger than the needle driver, the user generally will beguided by the needle driver slot such that the needle driver engages oneor both sides of the slot as the needle driver is advanced toward theend of the slot. The sliding movement of the needle driver along theslot can provide a sensation of vibration or varying drag or ratchetingas the needle driver is moved along the slot. The inclined ratchetingsurface may comprise a first side for the entry zone which is inclinedat an angle and a second side that faces the stop that is inclined at agreater angle away from the axis to inhibit movement of the needledriver away from the end of the slot.

The inner surfaces of the needle driver slot can be configured in manyways to provide the user with feedback as the needle driver is beingadvanced toward the proximal end. For example, one or more of the uppershell or the lower shell may comprise undulating surface structures orprotruding surface structures to provide this feedback. For example,small dimples can be provided in one or more of the upper slot or thelower slot to provide the user with tactile feedback. The protrusionsand/or recesses provided along the inner surfaces of the needle driverslot are generally symmetrically arranged along either side of theneedle driver slot to provide the user with a sense of depth within theslot as the needle is advanced. While the size of the structures thatare used can be varied in many ways, in many embodiments the structuresgenerally extend inwardly toward the needle driver slot at least about aquarter of a millimeter, for example at least a millimeter and generallywithin a range for about a 1/10 of a millimeter to about a millimeter oneither side of the needle driver slot.

FIG. 327B shows varied apertures 3273 along the needle driver slot 3272.The varied apertures generally comprise a concave surface and a tiporiented toward the needle driver slot. As the needle driver is guidedby the needle driver slot, the needle driver will generally engage oneor both surfaces. As the needle driver is advanced toward the stop onthe end, the needle driver provides tactile feedback to the user as theneedle driver moves along the concave portions and the tip portion ofthe needle driver slot. The surface structures provided along the innersurface of the needle driver slot can be provided on the upper needledriver slot or the lower needle driver slot or both. When the structuresare provided on both the upper needle driver slot and the lower needledriver slot, structures are generally aligned in order to provide theuser feedback as the needle driver is advanced.

FIGS. 328 to 333 show a chiral barrier in accordance with embodiments.

FIG. 328 shows a chiral barrier 3280 for placement on the left forearmof the surgeon. While the barrier can be formed in many ways, work inrelationship to embodiment suggests that the chiral barrier customizedfor a left forearm can be preferred. It is contemplated that barriersfor the left forearm for right-handed surgeons can be provided andbarriers for the right forearm for left-handed surgeons can be provided.The chiral barrier has the advantage of providing better fit to aplurality of left-handed users and a plurality of right-handed users.Although reference is made to a chiral barrier, it is contemplated thatthe barrier can be symmetric and used on either arm. For example, thebarrier may comprise a conic section with conic ends having a pre-formconic shape, or can be chiral as described herein. The barrier comprisesa volar edge on a volar side 3281 and a dorsal edge on a dorsal side3282. The volar edge can separate from the dorsal edge when advancedover the forearm for placement.

Referring again to FIG. 328, the chiral barrier comprises a dorsal side3282 and a ventral or volar side 3281, a proximal end 3283 and a distalend 3284. The proximal end is located toward the elbow of the user, andthe distal end is oriented toward the wrist of the user. The chiralbarrier comprises a plurality of tabs such as proximal tab 3285 a and adistal tab 3285 b. The plurality of tabs may be located on either thedorsal edge or the volar edge. The barrier may comprise a pre-formedmaterial such as a thermally formed material. The preformed material maycomprise a sheet of material having substantially uniform thicknesspre-formed thermoforming to desired shape to accommodate anatomicalstructures of the user. For example, the barrier may comprise shaping toaccommodate musculature near the elbow of the user and wrist movementand wrist anatomy in the wrist of the user. The chiral shape can becustomized with respect to a left arm for a right-handed user in orderto better accommodate the musculature of the proximal forearm and thewrist movement of the distal forearm. The barrier may comprise a barriermaterial as described herein in order to inhibit penetration or stickswith sharp objects such as needles.

The chiral barrier can be located along a coordinate reference system,in which the origin corresponds to a central point 3321 of the proximalforearm. The +X direction extends toward the volar side of the forearm;the +Y direction extends in a direction toward the radius of theforearm; and the −Z axis extends toward the distal end of the forearmnear the wrist.

FIG. 329 shows a top plan view of the barrier 3280 of FIG. 328 prior tothermal forming. The barrier comprises a proximal ergonomic end profile3286 on the proximal end 3283. The proximal end generally comprisesconvexly curved surfaces near the corners of the barrier on oppositesides and in generally tapered decreased length toward the center of thebarrier for example to accommodate musculature and flexing of theforearm toward the biceps of the user. The distal end 3284 of thebarrier may comprise may comprise an ergonomic distal end profile 3287.The distal end profile may comprise curved corners near the ends of thebarrier. The ergonomic distal end profile may be shaped to provide adecreased length of the barrier toward the wrist of the user. Thedecreased length of the barrier toward the distal end near the wrist ofthe user can allow the user to flex and extend the wrist with decreasedcontact on the distal end profile. In use the barrier may tend to movetoward the wrist of the user and the distal end profile having the shapeshown in FIG. 329 can provide improved comfort by appropriatelycontouring to the forearm near the wrist. The barrier may comprise alength extending between the proximal end and the distal end and thelength of the barrier can vary with location around the forearm of theuser. The ergonomic proximal end profile and the ergonomic distal endprofile can be arranged such that the length of the barrier is decreasedbetween the ergonomic distal end profile and the ergonomic proximal endprofile in relation to the corner sections or ends of the barrierdisplaced laterally away from the ergonomic inner portion of thebarrier. For example, the radial ridge length 3299 along the radialridge aspect 3289 of the barrier may be shorter than the volar length3291 along the volar aspect 3281 and the dorsal length 3292 along thedorsal aspect 3282 of the barrier. The ergonomic proximal end profile3286 and/or the distal end profile 8287 may comprise radial ridgeindicia 3293 and 3294 along the radial ridge aspect 3289.

The barrier comprises proximal tabs 3285 a and distal tabs 3285 bconfigured to allow the user an ergonomic fit. The proximal tabcomprises the proximal tab length 3288 a and the distal tab comprisesthe distal tab length 3288 b. The distal tab length is generally shorterthan the proximal tab length to provide improved comfort. The distal tablength generally comprises a length that is within a range from about20% to about 80% of the proximal tab length. The proximal tab maycomprise a length within a range of about ½ inch to about 2 inches forexample. The barrier may comprise one or more tab couplings 3295 forsecuring the barrier about the arm of the user. For example, theproximal tab and/or the distal tab, extending from the dorsal aspect3282 of the barrier, may comprise one or more tab couplings configuredto engage corresponding tab couplings disposed at the volar aspect 3281of the barrier.

FIG. 330 shows axes of the pre-formed barrier 3280. The barrier isgenerally pre-formed with a self-supporting sheath as shown in FIG. 328.The pre-formed barrier with the self-supporting sheath will generallyassume the shape shown in FIG. 328. The memory of the barrier allows thebarrier to fit well on many users. It allows the barrier to be stretchedslightly in order to fit a user. The barrier can be provided with strapsas described herein.

The barrier generally comprises a generally elliptical cross-section inthe preformed shape on the proximal end 3283 and it also comprises agenerally elliptical shape on the distal end 3284. Although reference ismade to an elliptical shape, the shape may comprise non-ellipticalshapes having the first dimension across longer than the seconddimension across perpendicular to the first dimension across. Forexample, the shape may correspond to an oblong shape along one dimensionor an egg shaped profile for example.

FIG. 330 shows primary axes for the proximal and distal portions in theself-supporting shape of the barrier. The primary axis refers to theaxis having the longest length of the cross-section of the barrier. Asecondary proximal axis 3303 b extends generally perpendicular to theprimary proximal axis 3303 a. On the distal end the primary axis 3304 aextends along the longest dimension of the cross-section of thepre-formed self-supporting barrier. A secondary axis 3304 b extendsperpendicular to the primary axis and may correspond to the shortestdimension of the cross-section through a center of the cross-section.

The self-supporting barrier may comprise a primary axis 3303 a having asubstantially vertical orientation on the proximal end and a primaryaxis 3304 a on the distal end rotated relative to the primary axiswithin an angle α as shown in FIG. 330. This rotation of the distalprimary axis relative to the proximal primary axis provides improvedcomfort to the user.

A person of ordinary skill and art will recognize that variousadaptations can be made of the self-supporting thermal-formed barrier asshown in FIGS. 330 and 328. For example, the barrier may comprise agenerally conic shape such that the primary end has a substantiallycircular cross-section and the distal end has a substantially circularcross-section in which the distal end has a substantially circularcross-section in which the distal end has a diameter less than theproximal end.

The inventors have conducted experiments with many shapes of pre-formedbarriers and determined that the chiral barrier as shown with referenceto FIGS. 330, 328 and 329 provides improved comfort. Although thebarrier can be provided with foam and foam can provide improved comfort,the inventors have determined that the chiral barrier as describedherein provides improved comfort when used with foam or without foam.The foam lining provided on the inner surface can provide improvedcomfort and can allow sizing to many shapes of users.

FIG. 331 shows a view from the proximal end 3283 of the barrier 3280toward the distal end 3284 of the barrier. As can be seen with referenceto FIG. 331, the proximal end comprises a generally oval shape having alongest dimension across and a shortest dimension across in which bothdimensions extend through the center of the proximal end. The distal endsimilarly comprises an oval shape having a maximum dimension acrossalong the primary axis and a shorter dimension across along a secondaryaxis orthogonal to the primary axis. The primary axis of the distal endis shown rotated to the primary axis of the proximal end. This rotationof the primary axis of the distal end in relation to the primary axis ofthe proximal end can help the user orient the wrist in an ergonomicposition during surgery which can last for several hours.

FIG. 332 schematically illustrates structures of chiral barrier 3280.The proximal end 3283 of the barrier comprises a primary (long) axis3303 a and a secondary (short axis) 3303 b having a length that isshorter than the primary axis. The distal end 3284 of the barriercomprises a primary (long) axis 3304 a and a secondary (short) axis 3304b. The long axis 3304 a on the distal end is rotated relative to thelong axis 3303 a of the proximal end. The rotation angle can be within arange from about 5 to 45 degrees, for example within a range from about10 degrees to about 30 degrees, and can be 20 degrees, for example.

The distal end can also be offset relative to an axis of the proximalend. A path can extend from the center 3321 of the proximal end 3283 tothe center 3322 of the distal end 3284. The path can be defined with thecenter of the barrier at locations between the proximal end and thedistal end. As the forearm comprises musculature and other chiralstructures, the shape profile of the forearm may comprise chirality. Thechiral barrier is shaped to generally correspond to the chirality of theforearm. The center points of the forearm define a curved chiral path3323 extending between the elbow and the wrist. At the proximal end, thebarrier is shaped to correspond to the shape of the forearm and thecurved central path of the forearm. The proximal end of the forearm canbe defined with a plane extending perpendicular to the pathcorresponding to the center of the forearm. The plane defines a z-axis3324 orthogonal to the cross-section through the forearm at the proximalend. The barrier is shaped similarly to the forearm. The proximalcross-section of the barrier comprises a central point 3322 and a plane3325 that extends substantially perpendicular to the barrier surface onthe proximal end. The z-axis 33224 from the center point of the barrieron the proximal end can be projected to the distal end. The inventorshave learned that the distal end is offset from this projection of thez-axis by an extending between the proximal end and the distal end. Thecenter of the forearm can be placed between the proximal end and thedistal end. The offset can be within a range from about 0.25 inches toabout 0.75 inches, for example.

FIG. 333 shows outer surface profiles 3326 of the barrier 3280 and thecurved path 3323 of the center of the barrier. The profile of thebarrier along the dorsal and volar aspects are shown. As the volaraspect of the forearm may comprise greater amounts of muscle mass thanthe dorsal aspect of the forearm, the barrier may comprise greateramounts of taper on the volar aspect of the forearm than the dorsalaspect. The curved path comprising the center of the barrier can extendin relation to changing muscle mass of the forearm.

The barrier comprises a shape memory material as described herein, whichmay comprise a thermoformed material. The thermoformed barrier materialcomprises a free standing self-supporting configuration with thegeometrical features as shown in FIGS. 328, 330-333, for example.

As noted above with reference to FIG. 328, the coordinate reference canbe defined as:

+X=volar aspect

+Y=radial aspect

Distal offset can be (8 mm, 20 mm)=(x,y)

Range from (0.2, 0.4) to about (2 cm, 4 cm) for example.

X offset (volar) can be within a range from about 0.2 cm to about 2 cm,for example within a range from about 0.5 cm to about 1.5 cm. Theyoffset (radial) can be within a range from about 0.4 to 4 cm, forexample within a range from about 0.8 cm to about 3 cm. Although offsetsare described, these are optional and in some embodiments the preformedbarrier may comprise no offset, while still being chiral, for examplewith rotations of the long axes on the ends of the barrier as describedherein.

The barrier as described herein can be configured with or withoutchirality.

The barrier can be configured with a shape memory material as describedherein, and configured with force characteristics suitable for placementon the forearm of the user. The barrier comprises a volar edge on avolar side and a dorsal edge on a dorsal side. The volar edge canseparate from the dorsal edge when advanced over the forearm forplacement. An amount of force to separate the volar edge from the dorsalby about one inch from a free standing configuration can be within arange from about 25 grams to about 400 grams, for example. The range canbe from about 50 grams to about 150 grams, for example. The massesprovide correspond to the amount of force to separate based on the forceof gravity, which will be readily understood by a person of ordinaryskill in the art.

The barrier may comprise a mass within a range from 10 grams to about250 grams, for example within a range from about 20 grams to about 75grams. The barrier may comprise a preformed thermoplastic shell having aweight within a range from about 20 grams to about 60 grams, forexample.

The barrier may comprise foam on an underlying surface beneath theshell. The weight of the barrier with foam can be within a range fromabout 35 grams to about 500 grams. The weight of the barrier with foamcan be a range from 20 grams to about 260 grams, for example within arange from about 20 grams to about 85 grams. The barrier may comprise apreformed thermoplastic shell and foam beneath having a weight within arange from about 30 grams to about 70 grams, for example.

The barrier may comprise a weight as described herein and the weight ofthe barrier can be less than the amount of force required to separatethe volar and distal ends for placement on the forearm of the user.

The barrier may comprise a longitudinal length within a range from about6 inches to about 11 inches. The barrier may comprise a ratio of thedistance across the proximal end to the distance across the distal endwithin a range from about 1.1 to about 1.5.

The barrier may comprise a shell wherein an underlying foam extendsdistally beyond the distal border of a shell of the barrier and whereinthe foam curves over a leading distal edge of the shell to pad theinterface of the shell when the barrier impinges on the wrist to providecomfort.

The barrier may comprise a shell having a radial curvature at a distaledge of shell with displacement within a range from about 3 mm to 1.5 cmto distribute a load of the barrier on a wrist of a user.

The barrier may comprise a shell, and inner foam padding may extendbeyond distal edge of the shell. The foam layer can extend beyond adistal end of the shell by a distance within a range from about 1 mm toabout 15 mm. The inner foam layer may comprise a thickness within arange from about 1 mm to about 15 mm.

The barrier may comprise a thickened distal edge.

The barrier can be configured to distribute a load when device abuts thedorsal or radial or volar aspect of the wrist with motion of the wrist.

The barrier can be configured to allow movement of proximal or distalends of the barrier so as to allow greater amounts of movement of thewrist of the user relative to the barrier. For example, the barrier maycomprise extensions on the proximal end that allow the barrier to besubstantially fixed in relation to the proximal forearm of the user.Alternatively the barrier can be tighter on the proximal strap than thedistal strap in order to allow the user's distal forearm to move morethan the proximal forearm in relation to the barrier.

The barrier can be configured to couple to the proximal forearm in orderto move with the proximal forearm more than the distal forearm. Forexample, the barrier may comprise a distal strap that can be tightenedmore than the proximal strap, in order to allow the barrier to move withrotation of the wrist of the user, for example.

The barrier can comprise a layer of padding on the bottom and a layer ofmechanical barrier on the top, with magnets placed on the undersurfaceof the mechanical barrier between layer of padding and the layer ofmechanical barrier. The mechanical barrier can comprise a polymermaterial, and can have a thickness in the range of about 0.5 mm to about5 mm.

FIGS. 334A-334C illustrate the use of a needle handling system asdescribed herein. FIG. 334A shows a user U, such as a surgeon, securinga needle 3341 within a needle receptacle 3342 mounted on a barrier 3343coupled to the forearm VF of the user's non-dominant arm, as describedherein. As shown, the needle receptacle is disposed on the plane of thevolar forearm VF. To secure the needle in the needle receptacle, theuser sweeps the needle, grasped with a needle driver 3344, from a distalposition to a proximal position along the plane of the volar arm.Therefore, the needle is not directed towards the arm, and the risk ofneedle stick injury is minimized. FIG. 334B is a schematic illustrationof the top view of the user U as the user secures the needle 3341 in thebarrier-mounted needle receptacle 3342. The anatomical neutral plane NPof the user's arm is shown with respect to the coronal plane CP, whereinthe anatomical neutral plane is substantially orthogonal to the coronalplane. Securing a needle in the forearm-mounted needle receptacle doesnot require external rotation 3345 a of the arm or shoulders withrespect to the anatomical neutral plane, therefore allowing the user toengage only fine motor control, rather than gross motor control, toperform movements related to the dispensing and securing of needles. Tosecure the needle in the needle receptacle, the user can internallyrotate 3345 b the forearm F from the elbow E while holding the needle inthe needle driver 3344, therefore sweeping the needle along an arc 3346directed from the anatomical neutral plane NP towards the needlereceptacle plane 3347. The needle receptacle plane can be substantiallyparallel to the plane of the volar forearm carrying the barrier-mountedneedle receptacle. FIG. 334C schematically illustrates the path of theneedle during securement in the needle receptacle 3342. The needle movesproximally along the needle arc 3346 towards the needle receptacle plane3347. The needle arc can comprise a substantially flat portion 3348defined as a portion of the arc that coincides with the needlereceptacle plane or is within a small angle α with respect to the needlereceptacle plane, for example within about 10°. The needle receptaclemay be positioned such that its length 3342 l substantially correspondsto the length 3348 l of the substantially flat portion. Thus, when theneedle reaches the substantially flat portion of the arc as the usersweeps the needle along the arc towards the needle receptacle, theneedle can reach the entry zone of the needle receptacle and be securedwithin the secure zone of the needle receptacle.

FIG. 335 illustrates an exemplary embodiment of a needle receptacle 3350comprising a cover 3351 for the needle driver slot 3352. A needle driverslot cover may provide an additional safety feature by more securelyenclosing the ends of the needle 3353 within the needle receptacle, andpreventing the accidental dislodging of a needle placed within thesecure zone 3354. The needle receptacle may be any needle receptacle asdescribed herein that comprises a slot or a groove 3352 within which aneedle driver may be moved while the needle grasped by the needle driveris secured in the needle receptacle. The needle driver slot cover 3351can comprise a flexible strip with a slit 3355 going through a portionof the flexible strip covering the needle driver slot. Alternatively,the needle driver slot cover can comprise opposed overlapping flexiblestrips covering the needle driver slot, such that the needle driver canmove through the slot between the overlapping strips. The flexible stripcan elastically deform 3356 to accommodate translation of the needlefrom the entry zone 3358 to the secure zone 3354 via translation of theneedle driver tip 3357 within the needle driver slot. FIG. 336illustrates another exemplary embodiment of a needle receptacle 3360comprising a cover 3361 for the needle driver slot 3362. The needledriver slot cover may comprise flexible strips as described withreference to FIG. 335. In addition to a longitudinal slit 3363 to allowtranslation of the needle driver therein, the cover may further comprisea plurality of vertical or transverse slits 3364. The vertical slits cancreate a plurality of vertical segments 3365, wherein the needle drivermoves through the vertical segments as it is translated along the needledriver slot. The vertical segments may be coupled to the needlereceptacle at the bases 3366 substantially parallel to the longitudinalsides of the needle driver slot. For any embodiment of a needle driverslot cover comprising flexible strips, the strips may be transparent andcomprise silicone or polyethylene, for example.

FIGS. 337A-337D illustrate another exemplary embodiment of a needlereceptacle 3370 comprising a cover 3371 for the needle driver slot 3372.FIG. 337A shows the top view, FIG. 337B shows the end view, FIG. 337Cshows the side view, and FIG. 337D shows the bottom view of the needlereceptacle. As shown in FIG. 337A, the needle driver slot cover 3371 ispositioned over the needle driver slot or groove 3372. In the default or“closed” configuration, the cover substantially covers the needle driverslot. When a needle driver is translated along the needle driver slot,the cover may be configured to slide along the longitudinal needledriver slot axis 3373 (in the direction shown by the arrow 3374) toexpose the needle driver slot, thereby allowing the needle driver tosecure a needle within the secure zone 3375. When the needle driverexits the needle driver slot, the cover may be configured to slide backto resume the default closed configuration. The needle driver slot covermay be configured to slide by translating within one or more rails 3376parallel to the needle driver slot axis. As shown in FIGS. 337B and337D, the one or more rails 3376 may comprise grooves in the bottomshell 3377 or housing of the needle receptacle, wherein the needledriver slot cover can fit into the grooves to couple to the bottomshell. The grooves may extend through the end of the bottom shell, toallow the cover to translate towards the secure zone 3375 to the fullextent possible. As shown in FIGS. 337C and 337D, a spring 3378 may bemounted under the bottom shell and coupled to the needle driver slotcover. The spring 3378 can constrain the translation of the cover awayfrom the entry zone 3379 as the needle driver translates along theneedle driver slot towards the secure zone 3375, and pull the cover backtowards the entry zone to the closed position after the needle driverexits the needle driver slot.

FIG. 338 illustrates an exemplary embodiment of a needle receptacle 3380comprising a compressive cover 3381 for the needle driver slot 3382. Theneedle receptacle, which may be any receptacle as described hereincomprising a needle driver slot, may comprise a needle driver slot coverconfigured to slide along a vertical axis 3383 that is substantiallyorthogonal to the longitudinal axis 3384 of the needle driver slot. Inthe default or “closed” configuration, the cover may be covering theneedle driver slot, such that the needles disposed within the securezone are substantially covered. The cover may be configured to slide upwhen a needle driver translates along the needle driver slot to secure aneedle, and return to the default “closed” configuration when the needledriver exits the needle driver slot. For example, the cover may comprisea mechanism similar to the spring mechanism described with reference tothe embodiment of FIGS. 337A-337D. In this configuration, the needledriver slot cover can compressively push the ends of the needlesdisposed within the secure zone 3385 downwards into the oppositelongitudinal edge of the needle receptacle housing, thereby furthersecuring the needles inside the receptacle. Such a configuration may beparticularly useful for the securing of small needles, since smallneedles may have some freedom of movement even when secured within thesecure zone. Compressively pushing the needles downwards against theneedle receptacle housing can help ensure that the ends of the needlesare contained within the receptacle housing.

FIG. 339 illustrates another exemplary embodiment of a needle receptacle3390 comprising a compressive cover 3391 for the needle driver slot3392. The needle driver slot cover can comprise a foam strip 3393mounted laterally above the needle driver slot. The foam strip mayfunction as a spring member, providing downward compression in thevertical axis 3394 substantially orthogonal to the longitudinal axis3395 of the needle driver slot. In the default or “closed”configuration, the foam strip covers the needle driver slot. When aneedle driver enters the needle driver slot and begins to translatealong the slot, the foam strip may be compressed upwards along thevertical axis to allow the needle driver to translate along the slot.When the needle driver exits the slot, the cover can spring back to thedefault configuration, compressively pushing the needles 3397 disposedin the receptacle downwards into the opposite longitudinal edge of thereceptacle housing. The lower edge of the foam strip may further belined with a rigid material 3396, such as a plastic strip, in order tofacilitate the application of the downwards compressive force to theneedles, particularly when the cover is in contact with andcompressively pushing against the tips of the needles.

FIGS. 340A-340C illustrate another exemplary embodiment of a needlereceptacle 3400 comprising a compressive cover 3401 for the needledriver slot 3402. FIG. 340A shows an exploded view, FIG. 340B shows anoblique view, and FIG. 340C shows a top view of the needle receptacle.As shown in FIG. 340A, the needle receptacle 3400 may comprise a bottomshell or housing 3403 having a planar needle slot 3404 to receive one ormore needles N, and an upper cover 3405 coupled to the bottom shell andconfigured to contain the needles within the planar needle slot. Theupper cover may comprise a transparent material to allow a user to viewthe needles secured within the needle receptacle. The bottom shell maycomprise a needle driver slot 3402 to allow translation of the needledriver therein. The bottom shell may further comprise a filleted recess3406 to receive a first compressive member 3407 such as a foam strip,configured to compress the needle disposed in the planar needle slotagainst the upper cover to secure the needle within the needlereceptacle, as described herein. The bottom shell may further comprise alead-in chamfer 3408 to guide the needle, grasped by the needle driver,into the plane of the needle slot. Additionally, the bottom shell maycomprise a mounting surface 3409 for the compressive needle driver slotcover, the mounting surface comprising an upper longitudinal edge of theneedle driver slot. The compressive needle driver slot cover 3401 maycomprise a compressive member such as a foam strip 3401 f mounted to themounting surface, laterally above the needle driver slot. The foam stripmay be lined with a rigid material (e.g., plastic strip 3401 p) at thebottom edge to further facilitate the application of the downwardcompressive force to the needle tip. As shown in FIG. 340C, thecompressive needle driver slot cover can provide downward compressiveforce CF along a vertical axis substantially orthogonal to thelongitudinal axis 3402 l of the needle driver slot, so as to push theneedles disposed in the planar needle slot downwards against theopposite longitudinal edge 3403 e of the bottom shell. In use, thecompressive member may be displaced by translation of the needle driveralong the needle driver slot, and upon removal of the needle drivercompressively push the needles downward against the longitudinal edge ofthe bottom shell opposite the mounting surface. The configuration asshown in FIGS. 340A-340C can further improve safety of the needlereceptacle by ensuring that the sharp ends of the needles disposedwithin the needle receptacle do not protrude through the needle driverslot, and by increasing the needle surface area that is in contact withthe first compressive member configured to secure the needle within theneedle receptacle.

FIGS. 341A-341C illustrate exemplary embodiments of a backlit needlereceptacle. FIG. 341A shows a needle receptacle 3410 a that is lit fromone longitudinal end of the needle receptacle. The body of the needlereceptacle, such as the top and/or bottom shell of the needle receptacleas described herein, may be optically coupled to a light source, such asone or more optical fibers 3411 or light-emitting diodes (LEDs). Theneedle receptacle body 3412 may comprise a light guide, configured totransmit light 3413 from the light source throughout the body of theneedle receptacle via total internal reflection. For example, the needlereceptacle body may comprise one or more optical grade materials such asacrylic resin, polycarbonate, or epoxy. FIG. 341B shows a top view andFIG. 341C shows a side view of a needle receptacle 3410 b that is litfrom the bottom side 3414 of the needle receptacle. The bottom side ofthe bottom shell of the needle receptacle may be optically coupled to alight source, such as one or more LEDs 3415 or optical fibers. The body3412 of the needle receptacle, such as the top and/or bottom shell, maycomprise a light guide configured to transmit light 3416 from the LEDsthroughout the needle receptacle body. A backlit needle receptacle asshown in FIGS. 341A-341C may help the user visualize the needlereceptacle or parts thereof (e.g., needle driver slot), therebyfacilitating the securing of needles N within the needle receptacle. Inaddition, a backlit needle receptacle can facilitate user counting ofneedles N secured within the receptacle.

FIGS. 342A-342E schematically illustrate various configurations of aneedle driver slot of a needle receptacle. As described herein, a needlereceptacle may comprise a needle driver slot or groove to allow thetranslation of a needle driver within the slot while the needle issecured in the needle receptacle. The needle driver slot often comprisesan upper groove in a top shell of the needle receptacle and acorresponding lower groove in a bottom shell of the needle receptacle.FIG. 342A shows a needle driver slot configuration wherein the uppergroove 3421 and the lower groove 3422 are uniform. The plane of the topshell 3423 may be parallel to the plane of the bottom shell 3424, andthe upper groove and the lower groove may be aligned in position. FIG.342B shows a needle driver slot configuration wherein the upper groove3421 has a larger width A than the width B of the lower groove 3422.Such a configuration can help conform to the shape of the needle drivertip, which often narrows in width at the tip. FIG. 342C shows a needledriver slot configuration wherein the walls of the upper 3421 and lowergrooves 3422 are rounded or radiused. The rounded walls 3425 of theupper and lower grooves may help improve the receipt of the needledriver tip within the needle driver slot. FIG. 342D shows a needledriver slot wherein the walls of the upper 3421 and lower grooves 3422are beveled 3426 to better conform with the dimensions of the needledriver tip. FIG. 342E shows a needle driver slot wherein the walls ofthe upper 3421 and lower grooves 3422 are curved to form a subsection ofa prolonged curving plane, such that the cross-sectional profile of theneedle driver slot comprises a curved v-shape 3427. FIG. 342F shows aneedle driver slot wherein the walls of the upper 3421 and lower grooves3422 are angular and collinear, such that the cross sectional profile ofthe needle driver slot comprises a v-shape 3428. The variousconfigurations of the needle driver slot can help improve theconformation of the needle driver slot to the shape of the needle drivertip, thereby facilitating the insertion of the needle driver tip intothe needle drive slot and improving the stability of translation of theneedle driver tip within the needle driver slot during securement of theneedle.

FIGS. 343A-343G illustrate exemplary embodiments of a swaged needledevice for dispensing and securing a swaged needle. Swaged needles SNwith a running suture S can be used for repeated passage of a needlewith the same suture thread in closing an incision. The swaged needledevice can be provided in a similar manner as described herein for asuture package and a needle receptacle, for example mounted to a barriercoupled to a forearm of a surgeon. A swaged needle device comprises oneor more swaged on needles with an attached running suture, coupled tothe device such that the tip or leading end of the needle is renderedinnocuous. As shown in FIGS. 343A and 343B, a swaged needle device 3430a can comprise a spindle 3431 for the suture to be wrapped around, andan opening 3432 on a top surface 3433 of the device for securing theneedle. The spindle may comprise a side wall with a lateral grooveand/or lateral borders or protruding edges at the top and bottom edgesof the spindle, to securely hold the suture wrapped around the sidewall. The swaged needle may be securely coupled to the opening via oneof various means such as a magnetic coupling between the needle and thetop surface of the device, or a foam member disposed below the topsurface and configured to receive the tip of the needle inserted throughthe opening. FIGS. 343C and 343D show an oblique view and a sidecross-sectional view of a swaged needle device 3430 b comprising aspindle 3431 and a top container 3434 for the swaged needle SN. Thesuture S attached to the swaged needle can be wrapped around thespindle, wherein the spindle can be fixed or configured to rotate todispense the suture. The top container can comprise a recessed region3435 at the top surface of the device within which the swaged needle maybe placed, and a cover 3436 configured to cover the recessed region soas to secure the needle within the recessed region. Preferably, a swagedneedle device has a low profile of about 0.3 mm to about 1.5 cm inheight H, and a width W or diameter of about 1.5 cm to about 8 cm.

A swaged needle device as described herein may be stackable with anotherswaged needle device. For example, as shown in FIG. 343E, the bottomportion 3437 of each swaged needle device 3430 may be configured to nestwithin the top portion 3438 of another swaged needle device 3430, suchas a recessed region 3435 in the top surface of the device forcontaining the swaged needle. Alternatively, as shown in FIG. 343F, thetop portion 3438 of each swaged needle device 3430 may be configured tonest within the bottom portion 3437 of another swaged needle device3430, such as a recessed region in the bottom surface of the device. Inthe stacked configuration, the needle SN may be disposed within anesting region 3439 between two stacked swaged needle devices. Inembodiments of the swaged needle device comprising a top container forthe needle with a cover 3436, the cover may also be configured to nestwithin the nesting region. Two stacked swaged needle devices may becoupled to one another via one or more of a clip, magnetic coupling,velcro, or removable adhesives. Alternatively, a plurality of swagedneedle devices may also couple to one another as a side-by-side array,or as overlapping series of spindle devices. In use, a swaged needledevice 3430 may be coupled to a forearm barrier 145 as described herein,as shown in FIG. 343G. The swaged needle device may be coupled to thebarrier via a velcro attachment, magnetic coupling, or a removableadhesive, for example. A surgeon may remove a sterile swaged needle froma swaged needle device, use the needle with the running suture to closean incision, and secure the used needle within the swaged needle device.As shown, a plurality of swaged needle devices may be provided on thebarrier, wherein the plurality of swaged needle devices may comprisedevices providing swaged needles of different sizes. A swaged needledevice may comprise a stack of a plurality of swaged needle devices asdescribed herein. As shown, the barrier may additionally support one ormore suture packages 101 containing needles coupled to pop-off sutures,and one or more needle receptacles 331 for securing dispensed/usedneedles. The barrier may therefore provide a surgeon with an array ofsuture needle options including swaged and pop-off suture needles,wherein the array can be readily customized to fit a particularsurgeon's needs. To facilitate cutting of running sutures by thesurgeon, the barrier may be additionally provided with a suture cutter457 as described herein.

As described herein, a needle receptacle may be coupled to a distal endof a surgical tool, such as forceps, for the securing of needles by asurgeon within the near surgical field without requiring the passing ofneedles out of the near surgical field. A tool-mounted needle receptaclemay be particularly well-suited for the securing of small needles. Thetool-mounted needle receptacle can be configured to removably couple tovarious surgical tools without requiring the use of coupling tools(e.g., screwdrivers). A tool-mounted needle receptacle may be configuredto couple to a range of surgical tool sizes, for example via an elasticcap that fits onto the distal ends of tools of various sizes. In use,one or more suture packs containing suture needles with pop-off suturesmay be supported by the surgeon on a non-dominant hand, wrist, or arm,as described herein. The tool-mounted needle receptacle may be coupledto the distal end of a tool held by the surgeon with the surgeon'snon-dominant hand. The surgeon may dispense a suture needle from thesuture pack, install the suture, and secure the used needle in thetool-mounted needle receptacle, using the surgeon's dominant hand.Preferably, a tool-mounted needle receptacle is configured to support atleast 5 suture needles, in order to accommodate the minimum number ofneedles provided in a single suture pack. Ideally, a tool-mounted needlereceptacle is symmetric for left and right hand use.

FIGS. 344A-344C illustrate an exemplary embodiment of a tool-mountedneedle receptacle 3440. FIG. 344A shows a front view, FIG. 344B shows arear view, and FIG. 344C shows an exploded view of the tool-mountedneedle receptacle 3440. The tool-mounted needle receptacle comprises ahousing 3441 configured to secure one or more needles N therein, atool-mounting interface 3442 to couple the housing to a surgical tool,and a coupling mechanism 3443 to couple the housing to the tool-mountinginterface. As shown in the exploded view of FIG. 344C, the housing cancomprise a front shell 3441 a and a rear shell 3441 b configured tocouple together to form an enclosure for the needles. The front shellmay comprise a needle driver slot 3444 configured to allow translationof a needle driver tip therein, as described herein with respect tovarious embodiments of a needle receptacle comprising a planar needleslot and configured to be supported on a barrier. The housing canfurther comprise an elastomeric member 3445 also comprising a needledriver slot, coupled to an interior surface of the front shell such thatthe needle driver slots of the front shell and the elastomeric memberare aligned. The elastomeric member may comprise a material such as asilicone, configured to partially cover the needle driver slot of thefront shell to reduce the risk of having needle ends exposed through theneedle driver slot. The housing can further comprise a rigid backing3446 and a compressive member 3447 (e.g., a piece of foam) configured toexert a compressive force into the rigid backing when the housing isfully assembled. In use, the needle receptacle may be coupled to a toolheld in the non-dominant hand of a user, with the needle driver slotfacing the opposite (dominant) hand of the user. A needle driver holdinga needle in the mid-body portion of the needle can be placed at theentry zone 3448 of the receptacle and inserted along the needle driverslot, placing the needle in the planar needle slot formed between thecompressive member and the backing. The compressive member can compressduring translation of the needle driver in the needle driver slot, andwhen the needle driver exits the needle driver slot, can compressivelypush the backing into the elastomeric member, thereby securing theneedle in the secure zone 3449 within the planar needle slot between therigid backing and the elastomeric member. The tool-mounted needlereceptacle may be mounted on a surgical tool via the tool-mountinginterface, which may comprise an elastomeric cap configured to fit ontothe distal ends of various tools within a range of sizes. Thetool-mounting interface may comprise surface features 3442 f such as aplurality of protrusions to facilitate gripping and coupling of thetool-mounted needle receptacle to a tool. The rear shell may comprisethe coupling mechanism configured to couple the housing thetool-mounting interface, wherein the coupling mechanism may comprise aprotrusion configured to engage a corresponding cavity of thetool-mounting interface. One or more components of the housing maycomprise a transparent material to allow visualization of needlessecured within the receptacle.

FIGS. 345A-345D illustrate another exemplary embodiment of atool-mounted needle receptacle 3450. As shown in FIG. 345A, thetool-mounted needle receptacle 3450 comprises a circular array of cells3451 each configured to contain a needle N. A needle may be capturedbetween a cover 3452 a and a compressive member 3452 c to secure theneedle within the cell. Each cell may comprise a needle driver slot 3453extending radially inwards from the outer edge of the cell, the needledriver slot configured to allow a needle driver holding a needle to beinserted into and translated radially inwards along the needle driverslot to secure the needle in the needle receptacle. As best shown in theexploded view of FIG. 345B, the needle receptacle may comprise a cover3452 a, a compressive member 3452 c, and a backing 3452 d, wherein aneedle can be configured to be placed between the compressive member andthe cover, such that the compressive member pushes the needle againstthe cover to secure the needle within the cell. The cover, compressivemember, and backing may be coupled together in a fixed alignment to forma rotatable assembly 3452, wherein the needle driver slots of eachcomponent is aligned with the needle driver slots of the othercomponents. For example, the compressive member may be adhesivelycoupled to the backing, and the compressive member/backing assembly maybe coupled to the cover via a central hinge 3452 b configured to spacethe cover from the compressive member/backing assembly at a sufficientclearance to accommodate a thickness of a needle. The needle receptaclemay further comprise a housing 3454, wherein the rotatable assembly canbe coupled to the housing via the central hinge 3452 b so as to allowrotation of the rotatable assembly about the central axis 3450 a of theneedle receptacle. The needle receptacle may further comprise atool-mounting interface 3455 similar to the tool-mounting interfacedescribed in reference to the embodiment of FIGS. 344A-344C. The toolmounting interface may be coupled to the housing via a couplingmechanism 3456, such as a protrusion 3456 a of the housing configured toengage a cavity of the tool-mounting interface, with an optionalcoupling member 3456 b configured to secure the coupling between theprotrusion and the cavity. The cover may comprise a transparent materialto allow visualization of needles secured within the needle receptacle.The cover and/or the backing may comprise an elastomeric material toallow for translation of the needle driver along the needle driver slotwhile keeping the width of the needle driver slot minimal, to decreasethe risk that needle ends may be exposed through the needle driver slot.

As best seen in the close-up view of FIG. 345C, the housing 3454 maycomprise a first raised edge 3454 a extending along its circumference,the first raised edge forming a first circular recess 3454 b of thehousing within which the backing and the compressive member may benested. The first raised edge may comprise a bevel 3454 c and asubstantially flat portion 3454 d, wherein the substantially flatportion can be configured to be flush with the top surface of thecompressive member, and the bevel can be configured to facilitate theinsertion of the needle driver in the needle driver slot. The housingmay further comprise at least one notch 3454 e extending radiallythrough the first raised edge, configured to allow insertion of a needledriver tip therethrough. Preferably, the housing comprises two notchesdisposed opposite from one another across the vertical axis 3450 b asshown in FIG. 345D, wherein one is a left hand notch 3454 e 1 configuredto accommodate a left-handed user and the other a right hand notch 3454er configured to accommodate a right-handed user. The housing mayfurther comprise a second raised edge 3454 f protruding from the firstraised edge about the periphery of the housing, wherein the cover may beconfigured to nest within the second circular recess 3454 g formed bythe second raised edge. As best shown in FIG. 345D, the second raisededge may have a clearing or break 3454 h extending on either side of anotch 3454 e, the length of the clearing corresponding to the length ofthe outer edge of an individual cell. The clearing can help a useridentify the cell currently available for access, and facilitatelocation of the needle driver slot. As shown in FIG. 345B, the cover mayhave a larger diameter than the compressive member and the backing, andaccordingly, the second circular recess accommodating the cover may havea larger diameter than the first circular recess accommodating thecompressive member/backing assembly. The slightly larger diameter of thecover can help improve safety by preventing a secured needle frompotentially escaping the cell through the gap between the compressivemember and the first raised edge of the housing.

In use, the tool-mounted needle receptacle may be coupled to a tool heldin the non-dominant hand of a user with the rotatable assembly facingthe opposite (dominant) hand of the user. The notch of the housing maybe aligned with a needle driver slot of an unoccupied cell of therotatable assembly. To secure a needle, the user may align the tip of aneedle driver holding the needle with the notch of the housing, andtranslate the needle driver radially inwards along the needle driverslot to place the needle within the cell, between the compressive memberand the cover. The user may then release the needle from the needledriver, and rotate the rotatable assembly to align the notch of thehousing with the needle driver slot of the next unoccupied cell in therotatable assembly. For example, the user may push the needle driverupwards or downwards against the needle driver slot to rotate therotatable assembly about the central axis via the central hinge.

In many embodiments, the present disclosure provides systems and devicesfor securing one or more needles. The systems devices for securing oneor more needles described herein can be used to secure used needles(e.g., serve as a needle receptacle), used to dispense unused needles(e.g., serve as a suture package), or combinations thereof.

In many embodiments, the systems and devices provided herein utilize oneor more clips to physically secure a needle or other sharp surgicalinstrument. A clip can include any device used to hold an object at acertain position and/or orientation relative to the clip and/or anotherobject. For example, a clip can be used to hold one or more needles inplace within a needle receptacle or suture package so as to prevent theneedle(s) from falling out or becoming dislodged. A clip can constrainthe movement of the object, e.g., with respect to up to six degrees offreedom of movement such that the object cannot move relative to theclip and/or another object. Optionally, a clip can constrain movement ofthe object along certain directions while permitting movement alongother directions. In many embodiments, a clip is configured to compressan inserted object or portion(s) thereof in order to secure thephysically object. The compressive forces can be applied using a springor other flexible element that is sufficiently compliant to permitinsertion of the object into the clip and sufficiently stiff to securethe object in place.

FIG. 346 illustrates an exemplary embodiment of a device 3460 forsecuring a plurality of needles, in accordance with many embodiments.The device 3460 can be used to secure used needles, unused needles, orcombinations thereof. In many embodiments, the device 3460 includes aplurality of clips 3461 each used to secure a respective needle 3462.Each clip 3461 includes a first arm portion 3463 a and a second armportion 3463 b joined to each other via a base portion 3464. The firstarm portion 3463 a and second arm portion 3463 b can each include arespective slot 3465 a, 3465 b shaped to receive a respective portion ofan inserted needle 3462. The first and second arm portions 3463 a, 3463b can be arranged such that when the needle 3462 is inserted into theclip 343 a, the ends of the needle 3462 are securely enclosed within theslots 3465 a, 3465 b of the first and second portions 3463 a, 3463 b.Accordingly, when the needle 3462 is placed within the clip 3461, thereare no exposed ends that could potentially injure a user. The clip 3461can be formed from and/or include spring materials that applycompressive force against the ends of the needle 3462 within the slots3465 a, 3465 b in order to secure the needle 3462 in place.

Optionally, the first arm portion 3463 a and second arm portion 3463 bcan be spaced apart from each other so as to form a gap 3466 between thefirst and second arm portions 3463 a, 3463 b, such that a middle portionof the needle 3462 is exposed. In such embodiments, the received needle3462 is secured only at its ends and not at its middle portion. The sizeof the gap 3466 can be selected based on geometry (e.g., length and/orcurvature) of the needle 3462 in order to ensure that the ends of theneedle 3462 will not protrude from the first and second arm portions3463 a, 3463 b. The gap 3466 can be used to accommodate the tip of aneedle driver or other instrument for inserting the needle 3462 into theclip 3461 and/or removing the needle 3462 from the clip 3461.

The device 3460 can include any suitable number of clips, such as one,two, three, four, five, six, seven, eight, nine, ten, or more clips. Theclips can be arranged in a linear array along a longitudinal axis of thedevice 3460 so as to form a rack of clips. The plurality of clips can beintegrally formed with each other so as to form a single continuousdevice. Alternatively, the clips can be removably coupled so as topermit adjustments to the size of the device 3460.

FIGS. 347A-347D illustrate an exemplary embodiment of a device 3470 forsecuring a plurality of needles, in accordance with many embodiments.FIG. 347A illustrates a top view, FIG. 347B illustrates a side view,FIG. 347C illustrates a front view, and FIG. 347D illustrates a backview. The device 3470 includes a plurality of clips 3471 arranged in alinear array and each used to secure a respective needle 3472. The clips3471 of the device 3470 can be similar to the clips 3432 of the device3430.

In many embodiments, the device 3470 is used to dispense unused needlesas well as secure used needles, without requiring distinctly separatesections for each needle type. Used and unused needles can bedifferentiated from each other based their orientation within the device3470. For example, an unused needle 3473 can be positioned within thedevice 3470 in a “concave down” configuration with the ends of theneedle 3473 pointing downwards, as shown in FIG. 347D. Thisconfiguration can facilitate grasping of the exposed arched middleportion of the needle 3473 by a needle driver. A used needle 3474 can bepositioned in the device 3470 in a “concave up” configuration with theends of the needle 3474 pointing upwards, as shown in FIG. 347C. Unusedneedles 3473 can be dispensed from clips at the back section 3475 of thedevice 3470, while used needles 3474 can be secured using clips at thefront section 3476 of the device 3470, or vice-versa. Optionally, theback section of the device 3470 can be closed, e.g., by a back wall3477.

FIGS. 348A-B illustrate an exemplary embodiment of a device 3480 forsecuring a plurality of needles, in accordance with many embodiments.FIG. 348A illustrates a top view and FIG. 348B illustrates across-sectional side view. Each needle 3481 is secured by a respectiveclip assembly 3482 including a first clip 3483 a and a second clip 3483b. The first clip 3483 a and second clip 3483 b each include arespective slot 3484 a, 3484 b shaped to receive a respective end of theneedle 3481. The clips 3483 a, 3483 b can be formed from and/or includespring materials that apply compressive force against the ends of theneedle 3481 within the slots 3484 a, 3484 b in order to secure theneedle 3432 in place without any exposed ends. The first clip 3483 a andsecond clip 3483 b are arranged with the openings of the slots 3484 a,3484 b facing each other such that the needle 3481 can be inserted intothe clip assembly 3482 along a direction substantially parallel to theplane of the device 3480.

Optionally, the first clip 3483 a and second clip 3483 b can be spacedapart from each other so as to form a gap 3485 between the first andsecond clips 3483 a, 3483 b, such that a middle portion of the needle3481 is exposed. In such embodiments, the received needle 3481 issecured only at its ends and not at its middle portion. The size of thegap 3485 can be selected based on the geometry (e.g., length and/orcurvature) of the needle 3481 in order to ensure that the ends of theneedle 3481 will not protrude from the first and second clips 3483 a,3483 b.

By providing a plurality of such clip assemblies, the device 3480 can beused to hold a plurality of needles in a planar array. The device 3480can include any suitable number of clip assemblies, such as one, two,three, four, five, six, seven, eight, nine, ten, or more clipassemblies. The clip assemblies can be arranged in a linear array alonga longitudinal axis of the device 3481 so as to form a rack of clipassemblies. The plurality of clip assemblies can be integrally formedwith each other so as to form a single continuous device. Alternatively,the clip assemblies can be removably coupled so as to permit adjustmentsto the size of the device 3480.

FIGS. 349A-B illustrate an exemplary embodiment of a device 3490 forsecuring a plurality of needles, in accordance with many embodiments.FIG. 349A illustrates an oblique top view and FIG. 349B illustrates across-sectional side view. The device 3490 includes a housing 3491defining an elongate slot 3492 for receiving and securing one or moreneedles 3493. The slot 3492 includes a first slot portion 3494 a and asecond slot portion 3494 b shaped to receive respective portions (e.g.,ends) of the needle 3493. The portions of the housing 3491 surroundingthe first and second slot portions 3494 a, 3494 b can be formed fromand/or include spring materials that apply compressive force to the endsof the needle 3493, such that the housing 3491 itself serves as a “clip”for physically securing the needle 3493. Optionally, in embodimentswhere the needle 3493 is carrying a suture, the trailing portion of thesuture 3497 can also be received within the housing 3491, or carriedwithin a flexible multislot tube or ribbon coupled to the housing 3491.

In many embodiments, the slot 3492 extends to the upper surface of thehousing 3491 so as to define an elongate opening 3495 is formed alongthe length of the housing 3491. Optionally, the slot 3492 can extendbelow the plane of the needle 3493 towards the bottom surface of thehousing 3491. As can be seen in FIG. 349B, the positioning of theopening 3495 results in the needle 3493 being secured within the housing3491 by its ends, while the middle portion of the needle 3493 isexposed. The geometry of the slot 3492 permits insertion of a needledriver tip into the housing 3491 in order to grasp the exposed middleportion of the needle 3493, e.g., to remove an unused needle or toinsert a used needle. For example, a used needle can be secured byaligning the needle and needle driver with the slot 3492, sliding theneedle into the slot 3492 along the direction indicated by arrow 3496,then releasing the needle from the needle driver when the desiredposition has been reached. As another example, an unused needle can beremoved from the device 3490 by inserting the tip of the needle driverinto the opening 3495, grasping the exposed middle portion of the needlewith the needle driver, then sliding the needle within the slot 3492along the direction indicated by the arrow 3496 and out of the housing3491. Advantageously, this embodiment permits securing and/or dispensingof needles without opening or closing the housing 3491, thus improvingease of use.

FIGS. 350A-B illustrate an exemplary embodiment of a device 3500 forsecuring a plurality of needles, in accordance with many embodiments.FIG. 350A illustrates a top view and FIG. 350B illustrates a side view.The device 3500 includes a u-shaped housing 3501 including a first armportion 3502 a and a second arm portion 3502 b. Each arm portionincludes a slot 3503 extending along the length of the arm portion. Thefirst and second arm portions 3502 a, 3502 b can be arranged such thatwhen a needle 3504 is inserted into the housing 3501, the ends of theneedle 3504 are securely enclosed within the slots 3503 of the first andsecond arm portions 3502 a, 3502 b. The arm portions 3502 a, 3502 b ofthe housing 3501 can be formed from and/or include spring materials thatapply compressive force against the ends of the needle 3504 within theslots 3503 in order to secure the needle 3503 in place. Alternatively orin combination, each arm portion can include a lining 3505 formed from adeformable material (e.g., foam, silicone rubber, composites) tofacilitate retention of the needle 3503 within the slot. The lining 3505can be located on the upper interior surface 3506 a of the arm portion,the lower interior surface 3506 b of the arm portion, or on bothsurfaces.

In many embodiments, the first arm portion 3502 a and second arm portion3502 b can be spaced apart from each other so as to form a gap 3507between the first and second arm portions 3502 a, 3502 b, such that amiddle portion of the needle 3504 is exposed. In such embodiments, thereceived needle 3504 is secured only at its ends and not at its middleportion. The size of the gap 3507 can be selected based on the geometry(e.g., length and/or curvature) of the needle 3504 in order to ensurethat the ends of the needle 3504 will not protrude from the first andsecond arm portions 3502 a, 3502 b. The gap 3507 can be shaped toaccommodate insertion of a needle driver tip into the gap 3507, e.g., inorder to grasp the exposed middle portion of the needle 3504. Forexample, the needle driver can be used to deposit a used needle into thedevice 3500, e.g., by aligning and sliding the needle along the slot3503 from, the back portion 3508 a of the housing 3501 towards the frontportion 3508 b of the device 3501. Optionally, the housing 3501 can beclosed at the front portion 3508 b so as to “trap” the received needleswithin the housing 3501.

FIGS. 351A-C illustrate an exemplary embodiment of a device 3510 forsecuring a plurality of needles, in accordance with many embodiments.FIG. 351A illustrates a top view, FIG. 351B illustrates a side view, andFIG. 351C illustrates a front view. The device 3510 includes a housing3511 including an upper wall 3512 and a lower wall 3513 movably coupledto each other by a hinge member 3514. The upper and lower walls 3512,3513 may be movable relative to each other, e.g., along the directionindicated by arrow 3518. The space between the upper wall 3512 and lowerwall 3513 forms an elongate slot 3515 for receiving one or more needles3516. The hinge member 3514 can be spring-loaded to bias the upper wall3512 and lower wall 3513 towards each other such that the insertedneedle 3516 is secured within the slot 3515 by the compressive forcesexerted by the upper wall 3512 and lower wall 3513.

In many embodiments, the housing 3511 includes lateral walls 3517arranged to capture and enclose the ends of the needle 3516 when theneedle 3516 is received within the slot 3515. In the depictedembodiment, the lateral walls 3517 are joined to the upper wall 3512such that the lower wall 3513 is positioned between the lateral walls3517. In alternative embodiments, the lateral walls 3517 can joined tothe lower wall 3513, and the upper wall can be positioned between thelateral walls 3517.

In many embodiments, the upper wall 3512 includes an opening 3519connected to the slot 3515 such that a middle portion of the insertedneedle 3516 is exposed. In such embodiments, the received needle 3516 issecured only at its ends and not at its middle portion. The gap 3519 canbe shaped to accommodate insertion of a needle driver tip into the gap3519, e.g., while grasping the exposed middle portion of the needle 3516in order to insert and/or remove the needle 3516 from the device 3510.

FIGS. 352A-C illustrate an exemplary embodiment of a device 3520 forsecuring a plurality of needles, in accordance with many embodiments.FIG. 352A illustrates a top view and FIG. 352B illustrates a side view.The device 3520 includes a plurality of clips 3521 each used to secure arespective needle. Each clip 3521 can be u-shaped with a first armportion 3522 a and a second arm portion 3522 b, and the arm portions caneach include a slot 3523 shaped to receive a respective end of aninserted needle 3524. The first and second arm portions 3522 a, 3522 bcan be arranged such that when the needle 3524 is inserted into the clip3521, the ends of the needle 3524 are securely enclosed within the slots3523 of the first and second arm portions 3522 a, 3522 b. The clip 3521can be formed from and/or include spring materials that applycompressive force against the ends of the needle 3524 within the slot3523 in order to secure the needle 3524 in place without any exposedends. Similar to other embodiments herein, the arm portions 3522 a, 3522b can be spaced apart to form a gap 3525, such that the middle portionof the needle 3524 is exposed. In such embodiments, the received needle3524 is secured only at its ends and not at its middle portion. The sizeof the gap 3525 can be selected based on the geometry (e.g., lengthand/or curvature) of the needle 3524 in order to ensure that the ends ofthe needle 3525 will not protrude from the clip 3521. The gap 3525 canbe used to facilitate insertion of the needle 3524 into the clip 3521and/or dispensing of the needle 3524 from the clip 3521 using a needledriver or other instrument.

Each clip 3521 permits insertion of a needle 3524 along a horizontalorientation. Horizontal may be used herein to refer to an orientation inwhich the plane of the slot of the clip is aligned with and/orsubstantially parallel to the ground, such that the needle is insertedalong a direction aligned with and/or substantially parallel to theground (e.g., as indicated by arrow 3526). A device configured forhorizontal needle insertion may in some instances be safer than devicesconfigured for insertion along other directions (e.g., verticaldirection), and may also provide a lower profile for securing aplurality of needles.

In many embodiments, the plurality of clips 3521 of the device 3520 areconfigured to be stacked with each other. FIG. 352C illustratesexemplary configurations of the device 3520 in which a plurality ofclips are stacked together. Any suitable number of clips may be stackedtogether, such as two, three, four, five, six, seven, eight, nine, ten,or more clips. The clips may be vertically stacked such that each clipis located at a different height along the device 3520. The planes ofthe slots of each clip can be substantially parallel to each other suchthat each needle is inserted along a horizontal orientation. The heightsof the clips can be offset along the vertical direction to enable aclear path to insertion of the needle and to accommodate the needledriver tip. In many embodiments, when stacked, the gaps 3525 of theclips 3521 are aligned with each other so that the needle driver tip hasan unobstructed path to each clip.

The stackable clips 3521 of the device 3520 can be removably coupled toeach other, e.g., using snap fits, interference fits, interlockingstructures, and the like. In embodiments where removably coupled clipsare used, the number of clips in the device 3520 can be varied asdesired by removing or adding clips in order to accommodate acorresponding number of needles. Alternatively, the clips 3521 of thedevice 3520 can be permanently affixed to each other in a stackedconfiguration, e.g., using adhesives, fasteners, and the like, or bybeing integrally formed with each other.

FIG. 353 illustrates an exemplary embodiment of a clip assembly 3530 forsecuring a needle 3531, in accordance with many embodiments. The clipassembly 3530 can include a first clip 3532 and a second clip 3533. Eachclip can include a front outer side 3534 a, a back outer side 3534 b, afront inner side 3535 a, and a back inner side 3535 b. As used herein,“front” and “back” may be defined relative to the insertion direction3536 for the needle 3531, while “inner” and “outer” may be used to referto portions closer to and away from the needle 3531, respectively. Inmany embodiments, the inner sides 3535 a, 3535 b of each clip 3532, 3533are open so as to define a slot in the interior of the respective clipfor receiving a respective end of the needle 3531. The outer sides 3534a, 3534 b of each clip 3532, 3533 can be closed so as to enclose theends of the needle 3531 within the respective clip. The clips 3532, 3533can be spaced apart from each other by a certain amount so as toaccommodate the tip of a needle driver 3537 between the clips 3532,3533. Similar to other embodiments herein, the needle driver 3537 can beused to grasp the middle portion of the needle 3531 in order to insertit into the clip assembly 3530 along the insertion direction 3536. Wheninserted, the ends of the needle 3531 are enclosed within the clips3532, 3533, while the middle portion of the needle 3531 is exposed.

In many embodiments, the clips 3532, 3533 are each oriented at anoblique angle relative to the insertion direction 3536 for the needle3531, such that the sides 3534 a, 3534 b, 3535 a, 3535 b of each clip3532, 3533 are not parallel or orthogonal to the insertion direction3536. The oblique angle can be selected based on the geometry (e.g.,length and/or curvature) of the needle 3531 such that when the needle3531 is inserted along the insertion direction 3536 convex side first,as illustrated in FIG. 353, the front outer sides 3534 a of the clips3532, 3533 act as a stop to catch and constrain the ends of the needle3531. Accordingly, it can be seen that the orientation of the clips3532, 3533 determine the extent to which the needle 3531 can be movedalong the insertion direction 3536.

FIGS. 354A-G illustrate an exemplary embodiment of a device 3540 forsecuring a plurality of needles, in accordance with many embodiments.FIG. 354A illustrates a top view of the device 3540. The device 3540includes a housing 3541 including a upper wall 3542 and a lower wall3543. The upper wall 3542 and lower wall 3543 can be integrally formedwith each other. Alternatively, the upper wall 3542 and lower wall 3543can be provided as discrete components that are removably ornon-removably coupled to each other. A slot 3544 is formed between theupper wall 3542 and lower wall 3543 such that one or more needles can bereceived between the upper wall 3542 and lower wall 3543. The slot 3544can extend through the upper wall 3542 of the housing 3541 such that anelongate opening 3545 a is formed in the upper wall 3542. Alternativelyor in combination, the slot 3544 can extend through the lower wall 3543of the housing 3543 so as to form an elongate opening 3545 b in thelower wall 3543. Similar to the other embodiments presented herein, theelongate opening 3545 a and/or elongate opening 3545 b can be shaped toaccommodate a needle driver such that a needle can be inserted into thedevice 3540 by grasping the middle portion of the needle with the needledriver, then sliding the needle through the slot 3544 along thedirection indicated by arrow 3546. The ends of the inserted needle aresecured between the upper wall 3542 and lower wall 3543, while themiddle portion of the needle is exposed via the opening 3545 and/oropening 3546. The front end of the device 3540 can be closed so as toconstrain the extent of movement of the needle along the insertiondirection 3546.

In many embodiments, the upper wall 3542 includes a plurality of slitsor fenestrations 3547. Alternatively or in combination, the plurality offenestrations can be formed in the lower wall 3543. The fenestrations3547 can be arranged substantially parallel to each other along thelongitudinal axis of the device 3540. The spacing between fenestrations3547 can be used to modulate the overall stiffness of the upper wall3542 and/or lower wall 3543. For example, widely spaced fenestrationsmay result in a higher stiffness, while closely spaced fenestrations mayresult in a lower stiffness. The portions of the upper wall 3542 and/orlower wall 3543 between each adjacent pair of fenestrations can beconsidered to act as an individual “clip” for securing a respectiveneedle. Accordingly, the plurality of fenestrations 3547 can be used todefine a linear array of “clips” for securing a plurality of needleswithin the device 3540.

The upper wall 3542 and lower wall 3543 can be formed from and/orinclude spring materials that apply compressive force against the endsof the needle within the slot 3544 in order to secure the needle inplace. Accordingly, the lateral portions 3548 of the housing 3541joining the upper wall 3542 and lower wall 3543 can act as aspring-loaded hinge that biases the upper wall 3542 and lower wall 3543towards each other. The design of the lateral hinge portion 3548 can beused to tune compressive forces applied to the received needle. Forexample, as illustrated in FIG. 354C, the upper wall 3542 and lower wall3543 can be biased toward each other such that the height A of the slot3544 at portions away from the opening 3545 and/or opening 3546 can begreater than the height B of the slot 3544 at portions near the opening3546 and/or opening 3546. Optionally, as illustrated in FIG. 354D, theinner surface of the upper wall 3542 and/or the inner surface of thelower wall 3543 can include a lining 3549 formed from a deformablematerial (e.g., foam, silicone rubber, composites) to further facilitateretention of the needle within the slot.

In many embodiments, the interior surfaces of the upper wall 3542 andlower wall 3543 are arranged substantially parallel to each other, asillustrated in FIG. 354E. This arrangement can produce a substantiallyconstant resistance as the needle is advanced along the insertiondirection. In alternative embodiments, the interior surfaces can bearranged at an angle relative to each other, as illustrated in FIGS.354F and 354G, so as to form a linear array of “clips” with bevelededges. This arrangement can produce a linear increase in resistance asthe needle is advanced along the insertion direction within a single“clip,” followed by a drop in resistance as the needle exits one “clip”and enters the next “clip.” This variable resistance can provide tactilefeedback that allows the user to determine when the next “clip” has beenreached, e.g., for more accurate positioning of the needle within thedevice 3540.

FIGS. 355A-B illustrate an exemplary embodiment of a device 3550 forsecuring a plurality of needles, in accordance with many embodiments.The device 3550 includes a housing 3551 including a upper wall 3552 anda lower wall 3553. The upper wall 3552 and lower wall 3513 can beintegrally formed with each other. Alternatively, the upper wall 3552and lower wall 3553 can be provided as discrete components that areremovably or non-removably coupled to each other. A slot 3554 is formedbetween the upper wall 3552 and lower wall 3553 such that one or moreneedles can be received between the upper wall 3552 and lower wall 3553.The slot 3554 can extend through the upper wall 3552 of the housing 3551such that an elongate opening 3555 is formed in the upper wall 3512.Similar to the other embodiments presented herein, the elongate opening3555 can be shaped to accommodate a needle driver such that a needle canbe inserted into the device 3550 by grasping the middle portion of theneedle with the needle driver, then sliding the needle through the slot3554 along the direction indicated by arrow 3556. The ends of theinserted needle are secured between the upper wall 3552 and lower wall3553, while the middle portion of the needle is exposed via the opening3555. The front end of the device 3550 can be closed so as to constrainthe extent of movement of the needle along the insertion direction 3556.

The upper wall 3552 and lower wall 3553 can be formed from and/orinclude spring materials that apply compressive force against the endsof the needle within the slot 3554 in order to secure the needle inplace. In many embodiments, one or more fenestrations or slits 3557 areformed in the upper wall 3552 so as to define a corresponding one ormore tabs 3558 in the upper wall 3552. For example, as shown in FIG.355A, a pair of u-shaped slits 3557 are formed in the upper wall 3552 oneither side of the elongate opening 3555 so as to define a pair ofelongate tabs 3558 in the upper wall 3552 on either side of the elongateopening 3555. The longitudinal axis of the elongate tabs 3558 can bealigned with the longitudinal axis of the device 3550. The hinge portion3559 of each tab 3558 can be located near the front end of the device3550. Optionally, as illustrated in FIG. 355B (middle), the tab 3558 canbe biased inwards relative to the surrounding portions of the upper wall3552 so as to apply compressive forces to the received needle(s).Additionally, as illustrated in FIG. 355B (bottom), the inner surface ofthe tab 3558 and/or the lower wall 3553 can include a lining 3559 formedfrom a deformable material (e.g., foam, silicone rubber, composites) tofurther facilitate retention of the needle within the slot 3554.

Alternatively or in addition to the use of clips, the systems anddevices described herein can use other mechanisms to physically secureone or more needles. For example, deformable materials such as foam canbe used to entangle the end(s) of a needle in order to render itinnocuous. Entanglement can occur when the needle is pierced or tackedinto the deformable material. The deformable material can encapsulatethe needle end so as to protect the user from injury due to needlesticks, etc. Additionally, once entangled by the deformable material,the movement of the needle may be constrained so as to reduce the riskof the needle becoming loosened or dislodged. As another example,adhesive materials can be used to physically secure one or more needleswithin a device. The adhesive materials can be used to cover and/orencase the needle so as to constrain its movement, as well as to encasethe ends of the needle to render them innocuous.

FIG. 356 illustrates an exemplary embodiment of a device 3560 forsecuring a plurality of needles, in accordance with many embodiments.The device 3560 may be similar to the devices 3470 and 3480 previouslydiscussed herein. The device 3560 includes a housing 3561 including anupper wall 3562 and a lower wall 3563. The space between the upper wall3562 and lower wall 3563 forms an elongate slot 3564 for receiving andsecuring the ends of one or more needles 3565. The upper wall 3562includes an opening 3566 connected to the slot 3565 such that a middleportion of the inserted needle 3565 is exposed. In such embodiments, thereceived needle 3565 is secured only at its ends and not at its middleportion. The opening 3566 can be shaped to accommodate insertion of aneedle driver tip into the opening 3566, e.g., while grasping theexposed middle portion of the needle 3565 in order to insert and/orremove the needle 3565 from the device 3560.

In many embodiments, the housing 3561 includes lateral walls 3566arranged to capture and enclose the ends of the needle 3566 when theneedle 3566 is received within the slot 3565. In the depictedembodiment, the lateral walls 3567 are joined to the upper wall 3562such that the lower wall 3563 is positioned between the lateral walls3567. In alternative embodiments, the lateral walls 3567 can joined tothe lower wall 3563, and the upper wall can be positioned between thelateral walls 3567.

In many embodiments, the upper wall 3562 and lower wall 3562 can beformed from and/or include spring materials that apply compressive forceagainst the ends of the needle 3565 within the slot 3564 in order tosecure the needle 3565 in place. Alternatively or in combination, thedevice 3560 can include a pair of elongate blocks 3566 a, 3566 b formedfrom foam or any other deformable material suitable for entangling theends of the needle 3565 as it is inserted into the slot 3564. The blocks3566 a, 3566 b can be formed from the same material or from differentmaterials. The blocks 3566 a, 3566 b can be positioned between the upperwall 3562 and lower wall 3563 and be aligned with the longitudinal axisof the device 3560. The distance between the blocks 3566 a, 3566 b canbe determined based on the geometry (e.g., length and/or curvature) ofthe needle 3565 so as to be sufficiently far apart to allow the needle3565 to be advanced within the slot 3564 in a convex-first orientation,while also being sufficiently close together to cause deformation of thefoam by the ends of the needle 3565 as the ends are positioned withinthe outer limits of the blocks 3566 a, 3566 b. In many embodiments, thefoam can be used to retain the needle 3565 within the device 3560through one or more of the following mechanisms: deformation of the foamby the needle ends, piercing of the foam by the needle ends,entanglement and/or entrapment of the needle ends within the foam, orindirect tacking of the needle ends within the foam (e.g., tacking thatoccurs when the needle ends are drawn across the foam substantially inan orthogonal relationship relative to the surfaces of the foam blocks).For example, advancing the needle 3565 within the slot 3564 in anconvex-first orientation may result first in deformation of the foam,followed by a passive piercing of the foam as a secondary effect. Inmany embodiments, the amount of force to remove an inserted needle 3565from within the device 3560 is greater than the amount of force tointroduce the needle into the device 3560.

FIGS. 357A-C illustrate an exemplary embodiment of a device 3570 forsecuring a plurality of needles, in accordance with many embodiments.The device 3570 includes an upper u-shaped compression element 3571 anda lower u-shaped compression element 3572. Each compression elementincludes a respective first arm portion 3573 a and second arm portion3573 b. A slot 3574 is formed in each arm portion between the uppercompression element 3571 and lower compression element 3572 and shapedto receive a corresponding portion of an inserted needle 3575. In manyembodiments, the first arm portion 3573 a and second arm portion 3573 bare spaced apart by a gap 3576, such that a middle portion of theinserted needle 3575 is exposed. The gap 3576 can be shaped toaccommodate insertion of a needle driver tip into the gap 3576, e.g.,while grasping the exposed middle portion of the needle 3575 in order toinsert and/or remove the needle 3575 from the device 3570. In manyembodiments, the upper and lower compression elements 3571, 3572 form aclip that exerts compressive forces on the received needle 3575 in orderto secure it in place. In alternative embodiments, the upper and lowercompression elements 3571, 3572 are passive elements that do not exertcompressive forces on the needle 3575.

In many embodiments, the upper and lower compression elements 3571, 3572are shaped based on the geometry (e.g., length and/or curvature) of theneedle 3574 such that when the needle 3574 is inserted into the device3570, the ends of the needle 3574 protrude outward from the outer edgesof the compression elements 3571, 3572. The exposed ends of the needle3574 can be rendered innocuous through the use of adhesive casings 3577.The adhesive casings 3577 can be attached to the outer edges of thefirst and second arm portions 3573 a, 3573 b spanning the “boundaryzone” where the exposed needle ends are located. In many embodiments,the adhesive casing 3577 can be connected to both the upper compressionelement 3571 and lower compression elements 3572 so as to enclose theexposed needle ends, as illustrated in FIG. 357B. Once the needle 3574is advanced into the device 3570, the upper portion 3578 a and lowerportion 3578 b of the adhesive casing 3577 can be pressed together so asto physically secure the needle ends and thereby render the needle 3574innocuous, as illustrated in FIG. 357C. The adhesive bonds can besufficiently strong such that the upper and lower portions 3578 a, 3578b of the adhesive casing 3577 and needle 3574 cannot be easily separatedfrom each other once adhesively secured.

FIG. 358 illustrates an exemplary embodiment of a device 3580 forsecuring a plurality of needles, in accordance with many embodiments.The device 3580 includes a an lower surface 3581 having a plurality oflower adhesive panels 3582 and an upper surface 3583 having a pluralityof upper adhesive panels 3584. The size and shape of each adhesive panelcan be configured to span the entirety of a needle 3585 placed on thepanel such that the ends of the needle 3585 do not extend past theboundary of the panel. In many embodiments, the adhesive panel includesand/or is formed from an adhesive material capable of physicallysecuring the needle 3585 when the needle 3585 is placed on the panel.Optionally, light pressure may be applied to the needle 3585 in order toensure tight adhesion to the panel. In many embodiments, the needle 3585is first placed on the lower adhesive panel 3582. The correspondingupper adhesive panel 3584 is then folded along crease 3586 in order toenclose the needle 3585 and render it innocuous. The upper adhesivepanels 3584 can be separated from each other by cuts 3587 so as topermit each upper adhesive panel 3584 to be folded down independently.The adhesive bonds can be sufficiently strong such that the loweradhesive panel 3582, upper adhesive panel 3584, and needle 3585 cannotbe easily separated from each other once adhesively secured.Additionally, the adhesive panels can be formed from a material withsufficient strength and/or thickness such that the sharp end of theenclosed needle 3585 cannot pierce through the panels.

FIG. 359 illustrates an exemplary embodiment of a device 3590 forsecuring a needle 3591, in accordance with many embodiments. The device3590 includes a foam block or capsule 3592 and a clip 3593. In order tosecure the needle 3591, the sharp leading end of the needle 3591 ispierced or tacked into the foam block 3592. Optionally, the foam block3592 can include a protective outer shell to prevent the sharp end frompiercing through the surface of the foam block 3592 and becomingexposed. The clip 3593 is then used to secure the blunt trailing end ofthe needle 3591. Accordingly, both ends of the needle 3591 are renderedinnocuous.

FIGS. 360A-C illustrate an exemplary embodiment of a device 3600 forsecuring a plurality of needles, in accordance with many embodiments.The device 3600 includes a rack 3601 with a plurality of receptacles forholding a corresponding plurality of foam blocks or capsules 3602. Aneedle 3603 can be rendered innocuous by piercing or tacking the sharpleading end into the foam block 3602. Each block 3602 can optionallyinclude a protective outer shell configured to prevent the sharp endfrom piercing through the surface of the foam block 3562 and becomingexposed. The user (e.g., a surgeon) can then hand the entire rack 3601with the secured needle(s) to a second user (e.g., a scrub tech), suchthat the second user does not need to handle each needle individually,thus reducing the risk of needle sticks or other injuries during thehandover.

In many embodiments, each foam block 3602 also includes a tail 3604 atthe end of the block 3602 away from the end where the needle 3603 isinserted. Alternatively, the user can tack each needle 3603 into thefoam block 3602 using a needle driver 3604. The tail 3604 can enablehandling of the secured needle without requiring the user to directlytouch the needle itself, thereby improving safety. For example, a user(e.g., a surgeon) can tack the needle 3603 into the foam block 3602using a needle driver 3605, and a second user (e.g., a scrub tech) canhandle the secured needle 3603 using the tail 3604. Optionally, the tail3604 can be used to hang the secured needle 3603 onto a wall or othersurface 3606, as shown in FIG. 360C, e.g., to facilitate counting of theneedles during or after the surgical procedure in order to ensure thatall needles are accounted for.

The device 3600 can be used to secure only the sharp leading end of theneedle 3603 via the foam block 3602 without also securing the blunttrailing end of the needle 3603. While an unsecured trailing end may behazardous within the surgical field due to the potential for rippinggloves, catching on surgical garments, etc., it may not be necessary tosecure the trailing end in the embodiments where the needle 3603 isimmediately transferred to a scrub tech outside of the near surgicalfield. In alternative embodiments, the embodiment of FIGS. 360A-C mayfurther involve securing the trailing end of the needle 3603 with aclip, similar to the device 3560, such that both ends of the needle 3603are rendered innocuous.

FIG. 361A illustrates an exemplary embodiment of a device 3610 a forsecuring a plurality of needles, in accordance with many embodiments.The device 3610 a includes a housing 3611 enclosing a foam core 3612.The foam core 3612 can be affixed to the housing 3611 in a fixedposition and orientation via a tab or other fastener 3613 passingthrough the foam core 3612. The housing 3611 includes a curved slot 3614defining an insertion path for one or more needles 3615. The geometry(e.g., length and/or curvature) of the curved slot 3614 can bedetermined based on the geometry (e.g., length and/or curvature) of theneedle 3615 so as to permit insertion of the needle 3615 into theinterior space within the housing 3611. In many embodiments, a needle3615 is rendered innocuous using the device 3610 a according to thefollowing procedure. First, the sharp leading end of the needle 3615 isinserted into the housing 3611 via the slot 3614 along an insertiontrajectory such that the sharp end of the needle is away from the foamcore 3612. The needle 3615 is then rotated to tack or pierce the needleinto the foam core 3612, thus physically securing the needle within thedevice 3610 a. Optionally, one or more tabs 3616 can be positioned inthe interior of the housing 3611 in order to constrain and guide themovement of the needle 3615 within the housing 3611. This procedure canbe repeated with a plurality of needles in order to secure multipleneedles within the device 3610 a.

FIG. 361B illustrates an exemplary embodiment of a device 3610 b forsecuring a plurality of needles, in accordance with many embodiments.The components of the device 3610 b are similar to those of the device3610 a, with the exception that the device 3610 b includes a foam core3617 coupled to the housing 3611 via a rotational tab or otherrotational fastener 3618 permitting rotation of the foam core 3617relative to the housing 3611. In many embodiments, a needle 3615 isrendered innocuous using the device 3610 b according to the followingprocedure. First, the sharp leading end of the needle 3615 is insertedinto the housing 3611 via the slot 3614 along an insertion trajectorysuch that the sharp end of the needle 3615 is tacked or pierced into thefoam core 3617. The foam core 3617 is then rotated by pushing the needle3615 (e.g., using a needle driver or other instrument) along thedirection indicated by arrow 3619 so as to move the needle 3615 to therear of the housing 3611, thus making room for additional needles to beinserted.

FIGS. 362A-362D illustrate an embodiment of a needle receptacle 3620with a rotatable cover 3621. The needle receptacle may comprise acircular housing 3622 with a plurality of cells or compartments 3623 forstoring individual needles N. Each compartment may comprise curvilinearwalls 3624 separating the compartment from adjacent compartments,wherein a needle may be placed within each compartment with thecurvature of the needle substantially aligned with the curvature of thecurvilinear walls, thus maximizing the number of compartments availableon the needle receptacle. Each compartment may optionally furthercomprise a magnetic or adhesive base 3625 to securely couple the needleto the base of the compartment. The needle receptacle may furthercomprise a circular cover 3621 configured to couple to the housing viarotatable central hinge 3626. The cover may comprise a window 3627 thatcan be aligned with a single compartment to allow access to thecompartment. The window may be formed by curvilinear walls configured tosubstantially align with the curvilinear walls of the housingcompartments. The cover may be rotated about the central axis 3620 a ofthe needle receptacle to enclose a needle within a compartment, and toexpose an adjacent unoccupied compartment for the securing of the nextneedle. As shown in FIGS. 362B and 362C, the window may be formed withbeveled edges 3628 of the cover to cause a needle to lay flat when coveris rotated to align the window with the next compartment. For example,the edges of the curvilinear walls of the cover defining the window maybe beveled such that the top or exterior surface 3621 a of the coverextends over the bottom or interior surface 3621 b of the cover. Thecover and the housing may be configured to provide a clearance betweenthe bottom surface of the cover and the base of the compartment that isclose to the thickness of the needle. Optionally, as shown in FIG. 362D,the housing may further comprise a core 3629 at the center comprising afoam material, such that a needle placed inside a compartment may befurther secured by tacking an end thereof into the foam core. In use, auser may place a needle inside an empty compartment with the windowaligned over the compartment, then rotate the cover to align the windowover another empty compartment. A user may rotate the cover by grabbingthe edges of the cover with the fingers, or by pushing a needle drivertip against an edge of the window.

FIG. 363 illustrates another embodiment of a needle receptacle 3630 witha rotatable cover 3631. The needle receptacle of FIG. 363 may be similarin many aspects to the embodiment shown in FIGS. 362A-362D. For example,the needle receptacle may comprise a circular housing 3632 with aplurality of compartments 3633, and a circular cover 3631 coupled to thehousing having a window 3634 with similar dimensions as a singlecompartment, optionally having beveled edges 3637. The rotating covermay comprise a plurality of tabs 3635 coupled to the outer edge of thecover, to facilitate rotation of the cover by a user. The housing mayfurther comprise an outer border 3636 comprising a foam material,coupled to the internal surface of the outer wall of each compartment. Aneedle N placed inside a compartment may be further secured by tackingan end thereof into the foam border.

FIG. 364 illustrates another embodiment of a needle receptacle 3640 witha rotatable cover 3641. The needle receptacle of FIG. 364 may be similarin many aspects to the embodiments shown in FIGS. 362A-362D and FIG.363. For example, the needle receptacle may comprise a circular housing3642 coupled to a rotatable cover 3641 having a window 3643 to allowaccess to the housing. The housing may comprise a landing zone 3644configured to receive and securely couple to a needle. For example, thelanding zone may comprise a magnetic surface or an adhesive surface. Thewalls of the window may be oriented for placement of a needle in anyorientation with respect to the compartment of the housing. The covermay be configured to rotate in either direction about the central axis3640 a of the needle receptacle. The window may comprise beveled edges3645 as described in reference to FIGS. 362A-362D, wherein the bevelededges can cause a needle placed in a non-planar orientation to lay flatwhen the cover is rotated.

FIGS. 365A-365D illustrate an exemplary embodiment of a swaged needledevice 3650 for dispensing and securing a swaged needle SN, comprising arotatable cover 3651. The swaged needle device comprises a circularhousing 3652 coupled to a rotatable cover 3651, wherein the housingcomprises a plurality of compartments 3653 and the cover comprises awindow 3654 configured to provide access to a single compartment. Thehousing and the rotatable cover may be similar in many aspects to thehousing and rotatable cover as described in reference to FIGS.362A-362D. For example, each compartment may comprise spiral orcurvilinear walls separating the compartment from adjacent compartments,and the window may be sized and shaped to be similarly to a compartment.The window may comprise beveled edges 3655 to cause a needle SN placedwithin a compartment to lay flat when the rotatable cover is rotated toalign the window with an adjacent compartment. The swaged needle devicemay be preloaded with sterile swaged needles SN having running sutures Sattached thereto. A needle may be securely coupled to a compartment inone of many ways described herein with respect to various embodiments.For example, the base surface 3658 of the compartment may comprise amagnetic surface configured to magnetically couple to a needle, or anadhesive surface configured to adhere to the needle. The compartment maycomprise a foam member 3659 coupled to the base, into which an end ofthe needle may be inserted to secure the needle. The compartment maycomprise a clip coupled to the base, configured to compressively holdthe needle therein. The compartment may further comprise a needle driverslot or recess 3656 formed in the base surface 3658 of the compartment,below the middle portion of the needle body. The needle driver recesscan facilitate the grasping of a needle with a needle driver, or thesecuring of a needle in the compartment with a needle driver. Therunning sutures S attached the needles may be wrapped around a spindle3657 provided by the rounded outer surface of the housing, best shown inFIG. 365B. The housing may be configured to rotate about a central axis3650 a of the needle receptacle to facilitate the dispensing of therunning suture. One of the compartments may be provided without asterile swaged needle, such that the window may be aligned with theempty compartment when the swaged needle device is not in use. In use, asterile swaged needle may be removed from a compartment by firstaligning the window with the compartment containing the sterile needle,then grasping the needle with a needle driver and removing the needlefrom the compartment. The swaged needle may be used to close anincision, and then the suture may be detached from the needle. The usedneedle may be placed back in the compartment, and then the cover may berotated to expose the next sterile swaged needle to be used. A user mayrotate the cover by grabbing the edges of the cover with the fingers, orby pushing a needle driver tip against an edge of the window. Asdescribed in reference to the swaged needle device shown in FIGS.343A-343G, the device may be mounted on a barrier coupled to the forearmof a surgeon. A plurality of swaged needle devices providing swagedneedles of different sizes may be provided on the barrier. Further, twoor more swaged needle devices may be provided stacked on top of oneanother.

FIGS. 366A-366C illustrate an exemplary embodiment of an integratedsuture needle dispensing and securing apparatus 3660. The apparatus maycomprise a needle dispensing portion 3661 on a first end, and a needlesecuring portion 3662 on a second end opposite the first end. Bothportions may be encased within a single housing 3663 configured toprovide physically separated interior portions for sterile needles NS tobe dispensed and used needles NU to be secured. Both portions may beconfigured to hold needles securely in a planar slot between a top shellor cover and a bottom shell of the housing, for example via compressivemembers disposed between the top and bottom shells and configured tocompress the needles against the top shell. Both portions may furthercomprise a needle driver slot 3664 extending along a longitudinal axisof the apparatus, configured to allow translation of a needle driver tipalong the slot to secure the needle within the housing. The dispensingportion may be preloaded with sterile suture needles NS, wherein thesutures S may be wrapped around the planar needle slot and encased inthe housing. The sterile needles may be loaded into the dispensingportion in the orientation shown in FIG. 366A, such that needles areremoved from the dispensing portion with the curved body leading and theends trailing, to minimize risk of needle stick injury to the userduring removal of the needles. In use, a user may grasp a sterile sutureneedle with a needle driver and remove the needle from the dispensingportion by translating the needle driver tip along the needle driverslot towards the open end of the slot. After using the sutured needle,the suture may be detached from the needle, and the dispensed or usedneedle may be secured in the securing portion. To secure the usedneedle, the needle driver holding the used needle may be inserted intothe needle driver slot of the securing portion and translated towardsthe closed end of the slot.

Optionally, the integrated needle dispensing and securing apparatus maybe provided with a hinge 3665 (e.g., a living hinge) between thedispensing portion and the securing portion, to allow the apparatus tobe folded or collapsed along the hinge axis 3665 a as shown in FIGS.366B and 366C. For example, the hinge may be configured to allow foldingof the apparatus with the flat bottom shells of each portion facing eachother. The hinge can allow the apparatus to be packaged or stored in areduced length configuration.

FIG. 367 illustrates an exemplary embodiment of a suture needledispensing device 3670. The dispensing device may be similar in manyaspects to the needle dispensing portion of the integrated dispensingand securing apparatus described in reference to FIGS. 366A-366C. Forexample, the dispensing device may comprise a top shell coupled to abottom shell, wherein a plurality of sterile suture needles NS areconfigured to be secured in the planar slot between the top shell andthe bottom shell (e.g., secured via compression of needles into topshell by compression members coupled to bottom shell). The device cancomprise a needle driver slot 3671 configured to allow translation of aneedle driver tip therein to facilitate grasping and removal of a needlefrom the dispensing device. The sutures S attached to the needles may beenclosed in a flexible tail 3672 having a plurality of individualchannels for each of the sutures. Such a configuration for the storageof the sutures can help avoid kinking and/or knotting of the sutureswithin the dispensing device.

FIGS. 368A and 368B illustrate an exemplary configuration for coupling aneedle receptacle 3681 to a suture package 3682. The needle receptacle3681 may be coupled to a suture package 3682, such as any commerciallyavailable suture package pre-packaged with a plurality of sterile sutureneedles NS, and the suture package may be mounted on a barrier asdescribed herein, in order to reduce the footprint of the suture packageand needle receptacle on the barrier. For example, in many commerciallyavailable suture packages, a significant portion of the surface area ofthe package is unused, and the needle receptacle may be coupled to theunused portion of the suture package. The needle receptacle may bedirectly adhered onto the top surface of the suture package, or theneedle receptacle may be indirectly coupled to the suture package via amounting interface 3683 as shown in FIG. 368B, such as adhesive strips.

FIGS. 369A-369C illustrate another exemplary configuration for couplinga needle receptacle 3691 to a needle dispensing unit 3692. The needlereceptacle 3691, such as any needle receptacle described herein, may becoupled to the needle dispensing unit 3692, such as any commerciallyavailable suture package or any needle dispensing device or apparatus asdescribed herein, by way of a barrier mounting base 3693. The barriermounting base may comprise any material capable of providing sufficientrigidity to stably support the needle dispensing device or receptaclewhile mounted on the barrier. The barrier mounting base may comprise afirst portion 3693 a and a second portion 3693 b, wherein the firstportion is configured to couple to the needle dispensing unit (such assuture package as shown in FIG. 369A), and wherein the second portion isconfigured to couple to the needle receptacle. The needle dispensingunit and the needle receptacle may each be coupled to the barriermounting base by way of one or more adhesive members, magnetic coupling,velcro attachment, or mechanical coupling mechanisms such as a snap-fit.As shown in FIG. 369B of the top side of the barrier mounting base, thefirst portion may comprise one or more adhesive members 3694 configuredto adhesively couple to a rear surface of the needle dispensing device.The needle receptacle may be coupled to the second portion by way of anadhesive backing coupled to the rear surface of the needle receptacle.As shown in FIG. 369C of the bottom side of the barrier mounting base,the bottom surface of each of the first and second portions may compriseone or more adhesive members 3695 configured to couple to the barrier.Alternatively, the barrier mounting base may be coupled to the barrierby way of a velcro attachment or a mechanical coupling mechanism.

Optionally, the barrier mounting base may be provided with a hinge 3696between the first portion and the second portion, such as a livinghinge. The hinge may allow at least partial folding of the base alongthe hinge, such that the plane of the first portion may be positioned atan angle with respect to the plane of the second portion.

FIG. 370A schematically illustrates an exemplary configuration of aneedle dispensing unit 3702 and a needle receptacle 3701 mounted on abarrier 3703. The needle receptacle may comprise any needle receptacleas described herein, and the needle dispensing unit may comprise anycommercially available suture package or any needle dispensing device orapparatus as described herein. The barrier is shown coupled to a forearmF, wherein the needle dispensing unit and the needle receptacle aregenerally disposed on the volar forearm side. As shown, the plane 3704of the needle dispensing unit is disposed at an angle α with respect tothe plane 3705 of the needle receptacle, such that the needle dispensingunit and needle receptacle are not coplanar. Such a configuration may beachieved by way of a hinged mounting interface, such as the barriermounting base described in reference to FIGS. 369A-369C. Such aconfiguration may improve the conformation of the needle handling systemto the shape of the forearm, reducing the profile of the system whenmounted on the barrier.

FIG. 370B schematically illustrates another exemplary configuration of aneedle dispensing unit 3702 and a needle receptacle 3701 mounted on abarrier 3703. The needle receptacle may comprise any needle receptacleas described herein, and the needle dispensing unit may comprise anycommercially available suture package or any needle dispensing device orapparatus as described herein. The barrier is shown coupled to a forearmF, wherein the needle dispensing unit and the needle receptacle aredisposed on a plane of the volar forearm. As shown, the needledispensing unit and the needle receptacle are substantially co-planar,with the two units partially overlapping. Such a configuration may beachieved by coupling the needle receptacle to a portion of the needledispensing unit as described in reference to FIGS. 368A-368B. Such aconfiguration may maintain both the needle dispensing unit and theneedle receptacle in the plane of the volar forearm, while reducing theprofile of the needle handling system in comparison to a configurationwherein the needle dispensing unit and the needle receptacle arenon-overlapping and co-planar.

FIGS. 371A and 371B illustrate an exemplary configuration of a needlereceptacle 3711 mounted on a barrier 3712. The barrier may be aforearm-coupled barrier as described herein, and the needle receptaclemay be any needle receptacle as described herein. The barrier maycomprise a recess 3713 to receive a portion of the needle receptacletherein, such as a protrusion of the rear surface of the needle traphousing. The protrusion may be configured to fit into the recess of thebarrier such the surface 3714 of the needle receptacle entry zone 3715is substantially flush with the plane 3716 of the barrier. Such aconfiguration can reduce the profile of the needle receptacle mounted onthe barrier.

FIGS. 372A and 372B illustrate exemplary labels that may be provided forcommercially available suture packages to be used with a needle handingsystem described herein. Many commercially available suture packages,while labeled clearly on the outside packaging, comprise sterile innerpackaging with poorly visible labels or no labels indicating the sizeand/or type of the suture needle contained therein. When suture packagesare placed within the surgical field (e.g., on a Mayo stand), they aretypically stripped of their outer packaging such that only the sterileinner packaging is displayed. Due to the poor visibility of labeling orlack of adequate labeling on the inner packaging, it can often bedifficult for a surgeon to visually identify the size or type of sutureneedles contained in each package. To facilitate surgeon identificationand selection of a suture package containing the desired size and/ortype of needles, sterile adhesive labels may be applied to the innerpackaging of suture packs that clearly display the size and/or type ofthe contained needles. The sterile adhesive labels may comprise, forexample, large text and/or color coding sufficient for allowingidentification of the suture pack contents from at least 3 feet away.Such sterile adhesive labels may be provided with a needle receptacleand barrier assembly as described herein, such that a user may easilylabel the sterile inner packaging of a commercially available suturepackage to be used in conjunction with the needle receptacle and thebarrier. As shown in FIG. 372A, a large-size needle receptacle may beprovided with a set of adhesive labels 3720 a for larger-sized sutureneedles. As shown in FIG. 372B, a small-size needle receptacle may beprovided with a set of adhesive labels 3720 b for smaller-sized sutureneedles.

FIGS. 373A and 373B illustrate an exemplary embodiment of a forearmbarrier 3730 comprising sliding longitudinal panels 3731. The barriermay comprise a plurality of longitudinal panels 3731 that are coupled toone another, wherein each panel is configured to slide out fromunderneath another panel. Each panel may be longitudinally aligned alongthe length of the forearm. During storage, the barrier may lay flat inthe storage configuration 3732 as shown in FIG. 373A, thereby reducingstorage profile and facilitating packaging and shipping of the barrier.For use, the barrier may be wrapped around the forearm to cause thepanels to slide out appropriately to conform to the size and shape ofthe user's forearm, as shown in FIG. 373B. The barrier may be secured tothe forearm in the wrapped configuration 3733 via one of many closuremechanisms, such as a tab, a velcro strap, one or more adhesive members,or one or more mechanical fasteners.

FIGS. 374A and 374B illustrate an exemplary embodiment of a forearmbarrier 3740 comprising sliding c-shaped sections or “bracelets” 3741.The barrier may comprise a plurality of c-shaped sections 3471 that arecoupled to one another, wherein each section is configured to slide outfrom underneath another section. Each c-shaped section may be configuredto wrap around a portion of a user's forearm. During storage, theplurality of c-shaped sections may be in a nested configuration 3742 asshown in FIG. 374A, thereby reducing the storage volume of the barrier.For use, the inner sections of the nested bracelets may be pulled outrelative to the outer sections to achieve the extended configuration3743 as shown in FIG. 374B. In the extended configuration, the combinedlengths of the c-shaped sections can extend along the length of theforearm. The plurality of c-shaped sections may be coupled to oneanother such that, when the inner sections are pulled out to achieve thedesired combined length, the barrier remains at said combined lengthwithout the c-shaped sections recoiling or resuming the nestedconfiguration. The barrier may be stretched out to its full length andsubsequently coupled to the forearm, or the barrier may be coupled tothe forearm in the nested configuration and subsequently pulled out toits desired length. The barrier may be coupled to the forearm such thatthe innermost nested c-shaped section is disposed near a distal portionof the forearm, and the outermost c-shaped section is disposed near aproximal portion of the forearm.

FIG. 375 illustrates a barrier 3750 comprising one or more plug-ins 3751for electrically powered surgical tools. A forearm barrier as describedherein may be further provided with one or more plug-ins for one or moreelectrically powered surgical tools 3753, such as electrocautery pens orsuction tubes. In many instances, during a surgical operation,electrically-powered surgical tools are connected to a power source 3752disposed outside the near surgical field. The power cord connecting thetool to the power source is often clamped into a fixed position abovethe incision site, in order to prevent the tool from being accidentallydisplaced during use via pulling of the power cord or movement of thepower source. Rather than clamping the power cords near the incisionsite, a surgical tool may be connected to its power source via a plug-indisposed on the forearm-mounted barrier. The barrier plug-in can providea more secure coupling to the tool's power cord than a clamp disposedabove the incision site, thereby further reducing the risk of the toolbeing accidentally displaced during use. The one or more plug-ins may beprovided on the dorsal side of the forearm F, so that the cords do notobstruct the needle dispensing unit and/or needle receptacle provided onthe volar side of the forearm.

FIGS. 376A-376D illustrate a barrier 3760 comprising one or more toolloops 3761 for supporting one or more surgical tools 3672. As shown inFIG. 376A, the tool loops 3761 are preferably provided on the dorsalside of the forearm F, such that the tools 3762 coupled thereto do notobstruct the needle dispensing unit and/or needle receptacle provided onthe volar side of the forearm. A tool loop may comprise a tapering loopwith the larger end facing up and the smaller end facing down. Thetapering shape of the loop can facilitation insertion of a tool into theloop by a user, and stably support the tool therein. As shown in FIG.376B, which is a top view of the barrier comprising the tool loops, thetool loops are preferably mounted such that they are flush against theouter surface 3763 of the barrier. For example, a tool loop may comprisea partial loop, the two ends of which are attached to two differentpositions on the barrier, such that a portion of the complete loopcomprises an outer surface of the barrier. Alternatively, a tool loopcomprising a complete loop may be coupled to a recess in the outersurface of the barrier, such that the interior surface of the portion ofthe loop disposed within the recess is flush with the outer surface ofthe barrier. Such a configuration may facilitate the insertion of a toolinto a tool loop, by allowing a user to use the outer surface of thebarrier as a guiding surface in the insertion of the tool withoutinterference from a bump or a lip formed by the interior surface of thetool loop protruding over the outer surface of the barrier. A tool loopmay be aligned along a vertical axis 3764 as shown in FIG. 376C, or maybe aligned along an axis 3765 offset from the vertical axis by anon-zero angle α as shown in FIG. 376D. In particular, the tool loop maybe slanted with respect to the vertical axis such that the smaller endof the tool loop is pointed towards the elbow, away from the wrist. Sucha slanted tool loop can provide better ergonomics for the insertion of atool into the tool loop, by aligning the orientation of the tool loopgenerally with the direction of movement of the user's hand in insertingthe tool into the tool loop (an internal rotation of the elbow to sweepthe tool-holding hand from the incision site towards the barrier, asshown in FIG. 334B). The tool loops may be coupled to the barrier usingone of many methods described herein for coupling a device to thebarrier, such as adhesive coupling, magnetic coupling, or mechanicalcoupling. Preferably, the tool loops can be removably coupled to thebarrier (for example via velcro straps), such that a barrier may becustomized with any number or sizes of tools loops coupled to anyappropriate location of the barrier.

FIGS. 377A and 377B illustrate exemplary embodiments of surgical gowns3770 comprising integrated forearm barriers. As shown in FIG. 377A, theforearm portion of a sleeve of a surgical gown 3770 may be provided withan integrated forearm barrier 3771. The forearm barrier may comprise atab that may be used to couple barrier to a user's forearm in a fixedposition. The tab may be an exposed tab 3772 extending from the sides ofthe barrier and over the gown sleeve, or partially enclosed tab 3773,partially enclosed within the sleeve. As shown in FIG. 377B, the forearmportion of a sleeve of a surgical gown may comprise one or more pockets3774 configured to receive one or more barriers 3771 or one or moreportions of a barrier therein. Alternatively, the barrier may be coupledto a tie 3775 sewed onto an edge of the gown and configured the wraparound the gown.

FIGS. 378A and 378B illustrate exemplary staging devices suitable forincorporation with the needle handling systems as described herein. Astaging device may be configured to store one or more needle dispensingunits (e.g., unused suture packs) or empty needle receptacles, for easyaccess to additional units during an operation. As shown in FIG. 378A, astaging device may comprise an upper arm staging device 3780 a,configured to couple to an upper arm of the user U, and/or a cheststaging device 3780 b, configured to couple to the chest of the user. Asshown in FIG. 378B, an upper arm staging device may comprise anenclosure 3783 providing an interior space 3784 for storing theadditional suture packs 3781 and/or needle receptacles 3782. The upperarm staging device may further comprise a fastening mechanism 3785 tosecurely couple the device to the upper arm of a user, wherein thefastening mechanism may comprise a strap, a velcro strap, or any otherfastening mechanism for wearable devices.

FIGS. 379A-379C illustrate exemplary kits for suture handling systems.FIG. 379A shows an exemplary spinal/regional anesthesia kit 3790,comprising a barrier 3795, one or more spinal needles 3790 a, one ormore syringes 3790 b (#1-3), a sponge mount 3790 c and one or moresponges 3790 d, a bandage mount 3790 e and one or more bandages 3790 f,one or more instrument or tool loops 3793, one or more safety needles3790 g (#1-3), and a pouch 3790 h. FIG. 379B shows an emergency roomsuture kit 3791, comprising a barrier 3795, one or more instrument ortool loops 3793 (2-3) and a pair of scissors 3791 a, one or more swagedneedle devices 3791 b (1-4), a needle receptacle 3791 c for largeneedles, a needle receptacle 3791 d for small needles, a needle driver3791 e and forceps 3791 f, and one or more sponges 3791 g. FIG. 379Cshows a IV line placement kit 3792 comprising a barrier 3795, one ormore catheters 3792 a, suture 3792 b for closing (e.g., 3-0 Nylon),syringe 3792 c and needles 3792 d, a needle receptacle 3792 e, needledriver 3792 f, forceps 3792 g, and scissors 3792 h, and prep materials3792 i. The kits shown in FIGS. 379A-379C are provided by way of exampleonly, and many different kits may be assembled to accommodate specificuses or procedures.

FIGS. 380A and 380B illustrate exemplary needle receptacles suitable forincorporation with the needle handling systems as described herein. FIG.380A shows a needle receptacle 3800 a comprising a housing 3801 aforming an interior space that defines a needle storage chamber orneedle slot 3802. The housing also forms a lateral opening 3803comprising the needle entry aperture, through which a needle may beinserted into the needle slot 3802. The housing further defines a needledriver slot or channel 3804 extending longitudinally along an upperportion of the housing, wherein the needle driver slot is configured toaccommodate translation of the tip of a needle driver along the needledriver slot, as described herein. In use, a needle grasped by a needledriver may be inserted through the lateral opening with the tip of theneedle driver aligned with the needle driver slot, and then the needledriver tip may be translated in a direction away from the lateralopening and towards the closed end 3805 of the housing to secure theneedle within the needle slot.

The lateral opening 3803 may have a width 3803 a that is greater thanthe height 3803 b, in order to constrain the orientation of the needlesbeing inserted through the opening into a substantially lateralorientation. The lateral opening 3803 may be oversized with respect to aneedle to be placed into the needle receptacle, in order to facilitatethe insertion of the needle through the lateral opening. For example,the width 3803 a of the lateral opening may be greater than the lengthof the needle (or, in the case of a curved needle, the straight-linedistance between the two ends of the needle), and the height 3803 b ofthe lateral opening may be greater than the thickness or wire diameterof the needle. For example, the height may be greater than 10 times thethickness of the needle, such that a user could easily insert the needlethrough the lateral opening without having to carefully align the needlewith the opening.

The needle slot 3802 may have a width 3802 a, height 3802 b, and length3802 c, wherein the width 3802 a and height 3802 b may be similar orequal to the width 3803 a and height 3803 b of the lateral opening.Alternatively, the dimensions of the needle slot may be different fromthe dimensions of the lateral opening, as described herein in referenceto FIGS. 382A-D. The height 3802 b of the needle slot is preferably lessthan the length of a needle (or, in the case of a curved needle, thestraight-line distance between the two ends of the needle), in order toconstrain the needles stored within the needle slot into a substantiallylateral orientation.

The housing may be substantially box-shaped as shown in FIG. 380A,having a top wall, a bottom wall, and three lateral walls, wherein theneedle driver slot extends lengthwise along the top wall. Alternatively,the housing may comprise a single, continuous body or any number ofportions coupled together to collectively define the needle slot, thelateral opening into the needle slot, and the needle driver slot. Thehousing may comprise a rigid material, a flexible material, or acombination thereof. For embodiments of the housing comprising aflexible or deformable material, the width 3804 a of the needle driverslot 3804 is preferably less than the thickness or wire diameter of aneedle to be placed in the needle receptacle, to reduce the risk ofaccidental protrusion of a needle tip through the needle driver slotwhen the flexible material is flexed or deformed. For example, thehousing may comprise a flexible upper portion wherein the needle driverslot comprises a slit cut through the flexible upper portion, whereinthe flexible material can deform to allow translation of the needledriver tip through the slit.

FIG. 380B shows a needle receptacle 3800 b that may be similar in manyaspects to needle receptacle 3800 a of FIG. 380A. The needle receptacle3800 b comprises a housing 3801 b defining a needle slot 3802 therein, alateral opening 3803 into the needle slot, and a needle driver slot 3804extending along an upper portion of the housing. The housing 3801 bfurther comprises an extended portion 3806 that extends beyond thelateral opening 3803 of the housing. The extended portion may extendfrom the bottom portion of the housing as shown, wherein the uppersurface of the extended portion may be flush with the bottom surface ofthe needle slot 3802. The extended portion may function as a landingzone for the needles to be placed into the needle receptacle, wherein auser may place the tip of the needle driver holding the needle againstthe upper surface of the extended portion, then translate the needledriver along the needle driver slot to place the needle into the needleslot. The extended portion may be configured to fold up to cover andseal off the lateral opening 3803 once the needle receptacle is full.For example, the extended portion may comprise an adhesive or afastening mechanism to attach the extended portion to the upper portionof the housing when the extended portion is folded up, to cover thelateral opening.

Optionally, the needle receptacle 3800 a or 3800 b may be provided withone or more internal retaining mechanisms to securely hold the needlesin place within the needle slot 3802. For example, the needle receptacle3800 a or 3800 b may comprise a spring member 3806 as shown in FIG.380A, configured to compress the needles within the needle slot againstthe upper portion of the housing. The spring member may be coupled tothe bottom portion of the housing near the lateral opening 3803, suchthat in use, as a needle is translated along the needle slot away fromthe lateral opening and towards the closed end 3805, increasing load maybe applied to the needle against the upper portion of the housing. Theneedles placed within the needle slot can thus be held securely betweenthe spring member and the upper portion of the housing. Alternatively,the needle receptacle 3800 a or 3800 b may comprise one or more clips3807 as shown in FIG. 380B, extending along the length of the housingand facing the lateral opening 3803. Each clip 3807 may comprise anupper portion 3807 a, a lower portion 3807 b, and a hinge portion 3807 cconnecting the upper and lower portions, wherein the clip is configuredto apply a compressive force against a needle placed between the upperand lower portions. One or more clips may be coupled to the housing atthe lateral opening, such that a needle placed into the needle slot isdirected into the one or more clips, and held securely between the upperand lower portions of the clips as the needle is translated away fromthe lateral opening and towards the closed end 3805. Other suitableinternal retaining mechanisms may include brushes or other inwardlyprojecting members, adhesives, magnets, mechanical dividers, orcombinations thereof. The internal retaining mechanisms can provide asecure zone of the needle receptacle wherein from being unintentionallydislodged or removed.

FIGS. 381A and 381B illustrate exemplary needle receptacles suitable forincorporation with the needle handling systems as described herein. FIG.381A shows a needle receptacle 3810 a comprising a housing 3811 a, thehousing having an interior space defining a needle storage chamber orneedle slot 3812 a for storing a plurality of needles therein. The upperportion of the housing forms a needle driver slot or channel 3813 aconfigured to receive a tip of a needle driver holding a needle to beplaced in the needle receptacle. The housing 3811 a, needle slot 3812 a,and needle driver slot 3813 a may be similar in many aspects to thecorrespondingly named elements described with reference to FIGS. 380Aand 380B. However, rather than the lateral opening shown in FIGS. 380Aand 380B, the housing 3811 a forms a top opening 3814 a comprising theneedle entry aperture through which a needle may be inserted into theneedle receptacle. The top opening 3814 a may comprise a cut-out in theupper portion of the housing, for example. The top opening may define alanding zone and entry zone of the needle receptacle. The top openingmay be oversized with respect to the size of the needle to be insertedthrough the top opening, to facilitate the insertion of the needlethrough the top opening. For example, the length 3815 a of the topopening may be greater than the length of the needle (or, in the case ofa curved needle, the straight-line distance between the two ends of theneedle), and the width 3815 b of the top opening may be greater than thethickness or wire diameter of the needle (or, in the case of a curvedneedle, the distance between the midpoint of the needle body and themidpoint of a straight-line drawn between the two ends of the needle).Optionally, the length 3815 a of the top opening may be greater than thewidth 3815 b of the top opening in order to encourage the user to orientthe needle with the length of the needle (or, in the case of a curvedneedle, the straight-line distance between the two ends of the needle)substantially aligned with the length of the top opening.

FIG. 381B shows a needle receptacle 3810 b that may be substantiallysimilar in many aspects to the needle receptacle 3810 a. For example,the housing 3811 b forms an interior space defining the needle slot 3812b, and the upper portion of the housing defines a needle driver slot3813 b configured to receive a tip of a needle driver tip therein. Theupper portion of the housing further defines a top opening 3814 bthrough which a needle may be inserted. The top opening 3814 b maycomprise a cut-out in the upper portion of the housing, for example. Thetop opening 3814 b may be oversized with respect to the dimensions ofthe needle to secured inside the needle receptacle, to facilitate theinsertion of the needle through the top opening. While FIG. 381A shows ahousing 3811 a that is substantially box-shaped, the housing 3811 b ofFIG. 381B is generally arrow-shaped, wherein the closed end 3816 b ofthe needle receptacle forms the head of the arrow, and the second end3816 a adjacent the top opening forms the tail of the arrow.Accordingly, the top opening 3814 b may be shaped to conform to thecurvature of a curved needle, so as to encourage placement of the needlethrough the opening in an orientation with both ends of the needlepointing away from the direction of translation of the needle along theneedle slot. Other aspects of the housing 3811 b, needle slot 3812 b,and needle driver slot 3813 b may be similar in many aspects to thecorrespondingly named elements of needle receptacles 3800 a and 3800 bshown in FIGS. 380A and 380B.

Optionally, the needle receptacle 3810 a or 3810 b may further compriseone or more internal retaining mechanisms as described in reference toFIGS. 380A and 380B. The one or more internal retaining mechanisms cansecure the needles within the needles slot to provide a secure zone ofthe needle receptacle.

FIGS. 382A-382D illustrate optional configurations of a needlereceptacle as in FIGS. 380A-381B. To prevent the unintentional removalof the needles from the needle receptacle once the needles have beenplaced inside the needle slot, the height or depth of the needle slotmay vary along the length of the needle slot. For example, as shown inthe cross-sectional side view of FIG. 382A, a needle slot 3820 a mayhave an entry zone 3821 a near the needle entry aperture of the needlereceptacle and a secure zone 3822 a near the closed end of the needlereceptacle. The lower interior surface 3824 a of the needle slot, whichmay be formed by the bottom portion of the housing as described herein,may be positioned at a first elevation (or z-axis position) at the entryzone, and at a second elevation (or z-axis position) at the secure zone,the first elevation higher than the second elevation. Further, theneedle slot may have a first depth 3825 a at the entry zone and a seconddepth 3826 a at the secure zone, the second depth greater than the firstdepth. Thus, when a needle is inserted through the needle entry aperture(e.g., lateral opening or top opening as shown in FIGS. 380A-381B) andsubsequently translated away from the entry aperture and towards theclosed end of the needle receptacle, the needle transitions from theshallow entry zone at a relatively higher elevation into the deepersecure zone at a relatively lower elevation. The needle is thus storedwithin the secure zone at a lower elevation than the elevation at theentry zone, such that there is decreased risk of the needle beingaccidentally removed from the needle slot, particularly while the needlereceptacle is maintained at a substantially lateral or planarorientation. The shallow, higher-elevation entry zone 3821 may be formedby an elevated bottom portion of the housing near the entry aperture,for example. The needle slot may be shaped to transition gradually fromthe first thickness into the second thickness, with a transition zone3823 a in which the depth of the needle slot increases proportionally tothe position along the length (x-axis) of the needle slot.Alternatively, the needle slot may transition abruptly from the entryzone into the secure zone, for example with a vertical drop-off from thefirst elevation down to the second elevation.

FIG. 382B shows a cross-sectional side view of another exemplaryconfiguration of a needle slot 3820 b. Similarly to the needle slot 3820a of FIG. 382A, the needle slot 3820 b may comprise an entry zone 3821 bnear the entry aperture of the housing and a secure zone 3822 b near theclosed end of the housing, wherein the lower interior surface 3824 b ofthe needle slot may be positioned at a relatively higher elevation (orz-axis position) with respect to the elevation at the secure zone.However, the first depth 3825 b of the needle slot at the entry zone andthe second depth 3826 b of the needle slot at the secure zone may besimilar or substantially equal. Such a configuration may be achievedwith an upper portion of the housing having varying thickness along thelength (x-axis) of the needle receptacle, as shown in FIGS. 382C and382D. FIG. 382C is a transverse cross-sectional view of the needle slot3820 b along line A-A as shown in FIG. 382B, and FIG. 382D is atransverse cross-sectional view of the needle slot 3820 b along line B-Bas shown in FIG. 382B. Cross-section A-A of FIG. 382C shows thecross-section of the needle slot at the entry zone, where the upperportion 3827 of the housing, defining the needle driver slot 3828, has afirst thickness 3827 a. Cross-section B-B of FIG. 382D shows thecross-section of the needle slot at the secure zone, where the upperportion 3827 of the housing has a second thickness 3827 b that isgreater than the first thickness 3827 a. The greater thickness of theupper housing at the secure zone compensates for the relatively lowerelevation of the lower interior surface of the needle slot at the securezone to result in a needle slot depth 3826 b at the secure zone that issimilar to the needle slot depth 3825 b at the entry zone. The firstneedle slot depth 3826 a and the second needle slot depth 3826 b may bedimensioned to securely hold a needle between the upper and lowerportions of the housing. The needle slot may be shaped to transitiongradually from the first thickness into the second thickness, with atransition zone 3823 b in which the depth of the needle slot increasesproportionally to the position along the length (x-axis) of the needleslot.

FIGS. 383A-C show an exemplary needle receptacle 3830 configured tostore a plurality of needles in an ordered array. The needle receptacle3830 comprises a housing 3831, which forms an interior space thatdefines a needle storage chamber or needle slot 3832 for storing aplurality of needles. The housing also defines a needle entry aperturecomprising a lateral opening 3833, through which a needle may beinserted into the needle slot. The needle slot 3832 may comprise aplanar needle slot dimensioned to store the plurality of needles insubstantially planar or lateral orientation. The housing further definesa needle driver channel or slot 3834 extending along a length 3836 of anupper portion of the housing. The housing 3831, needle slot 3832,lateral opening 3833, and needle driver slot 3833 may be similar in manyaspects to correspondingly named elements of needle receptaclesdescribed herein, such as the needle receptacles described withreference to FIGS. 380A-381B. The needle slot may comprise a pluralityof segments 3835, each segment extending across the needle driver slotand along the width 3837 of the housing. Each segment may be configuredto hold a single needle therein, for example by way of securing elementsconfigured to immobilize each needle within a single segment of theneedle slot. For example, as shown, the upper portion of the housing maycomprise a plurality of securing elements such as a plurality of tabs3838, configured to secure each needle within a single segment. FIG.383B shows a cross-sectional view of the needle receptacle 3830 with thetab 3838 in the default configuration, wherein the needle N, disposedwithin a single segment of the needle slot 3832, is not yet secured inplace by the tab. FIG. 383C shows a cross-sectional view of the needlereceptacle 3830 with the tab 3838 in the secured configuration, whereinthe tab has been pushed down to secure the needle N between the tab andthe lower portion of the housing. Optionally, the plurality of tabs maycomprise an adhesive and/or a magnet to further secure the needlebetween the tab and the lower portion of the housing. The plurality oftabs can thus enable the storage of the plurality of needles within theneedle slot in a non-overlapping ordered array, wherein the needles maybe stored spaced apart from one another to facilitate visual counting ofthe needles stored inside the needle receptacle.

FIGS. 384A-384B show another exemplary needle receptacle 3840 configuredto store a plurality of needles in an ordered array. The needlereceptacle 3840 comprises a housing 3841 defining a needle storagechamber or needle slot 3842 for storing a plurality of needles, and aneedle entry aperture comprising a lateral opening 3843, through which aneedle may be inserted into the needle slot. The upper portion of thehousing further defines a needle driver channel or slot 3844 extendingalong a length 3846 of the housing. The housing 3841, needle slot 3842,lateral opening 3843, and needle driver slot 3843 may be similar in manyaspects to correspondingly named elements of needle receptaclesdescribed herein, such as the needle receptacles described withreference to FIGS. 380A-381B and 383A-C. The needle receptacle 3840 mayfurther comprise a plurality of dividers 3848 disposed within the needleslot 3842 and configured to divide the needle slot into a plurality ofsegments 3845, each segment extending along the width 3847 of the needlereceptacle and configured to hold a single needle therein. The pluralityof dividers may be coupled to the internal surface of the bottom portionof the housing, for example. In use, a needle may be inserted into theneedle receptacle through the lateral opening 3843, translated along theneedle slot in a direction away from the lateral opening, then releasedinto an empty segment of the needle slot that is farthest from thelateral opening. The needle may be stored spaced apart from otherneedles in the needle slot by way of the dividers separating theplurality of segments.

Optionally, as shown in FIG. 384A, to further secure a needle within asingle segment, the needle receptacle may be provided with one or moremagnets 3849 configured to hold the needle in place within the needleslot. For example, the bottom portion of the housing may have one ormore magnets integrated within or attached to the internal surface ofthe bottom portion, such that a needle placed onto the surface issecurely held in place by the one or more magnets. Optionally, as shownin FIG. 384B, the needle receptacle 3840 may be adapted to compress downinto a reduced-height configuration, to further stabilize the needlesinto the ordered array within the needle slot. For example, the upperand lower portions of the housing may be configured to compress togetherwhen a user pushes downwards onto the needle receptacle.

FIGS. 385A-385B illustrate an exemplary embodiment of devices 3850 and3855 for securing a plurality of needles, in accordance with manyembodiments. FIG. 385A illustrates a top view, FIG. 385B illustrates alongitudinal cross-sectional view. In the illustrated embodiment, theneedle trap 3850 can be a planar device that is comprised of severalzones: 1) an entry zone 3850 a, 2) an entryway or transition zone 3850 band 3) a secure zone 3850 c, in accordance with many embodimentsdescribed herein (e.g., needle trap 331). The needle trap 3850 maycomprise an upper structure 3851 and a lower structure 3852 that aresecurely coupled together around an outer portion of the needle trap3850. The needle trap 3850 may comprise a needle driver slot 3853extending through both the upper structure 3851 and the lower structure3852, the needle driver slot configured to provide clearance for aneedle driver along the entire length of the needle trap 3850 fortranslation of a needle 3853 from the entry zone 3850 a to the securezone 3850 c. The needle trap can further comprise a needle slot 3854that constrains the secured needles into a single needle depth arraywhen received by needle receiver 3855, to minimize overall depth profileand facilitate needle counting. The lower structure 3852 may comprise athrough opening 3859 that runs transverse to the long axis of the needletrap 3850, and may be located anywhere within the entry zone 3850 a andthe entryway or transition zone 3850 b. The through opening 3859 ofneedle holder 3850 may be configured to receive the needle receiver 3855and allow the needle receiver 3855 to slide freely or with a desiredresistance therethrough. The needle receiver 3855 may comprise aplurality of needle receiving tabs 3857 a and 3857 b, which may belocated on opposing sides of the longitudinal axis of the needlereceiver 3955 as shown in FIG. 385A. The plurality of needle receivingtabs 3857 a/b may be shaped so as to receive one or more needles 3858 inan orientation that would locate the sharp ends of the one or moreneedles 3858 away from the direction of movement when the one or moreneedles are placed against surface 3856 of the needle receiver 3855 andtranslated into the needle trap 3850 with the needle driver (i.e., suchthat the sharp ends of the needles face away from a user when the needletrap 3850 is donned and the needle receiver 3855 is loaded, to minimizeaccidental needle-stick injury). As shown in FIG. 385A, the needlereceiving tabs 3857 a/b can be spaced longitudinally such that oneneedle can be located between adjacent needle receiving tabs 3857 a/b.

The needle receiver 3855 may be translated into the needle trap 3850 byconveyance. The needle receiver, initially without needles, may be slidealong the underside of the lower structure 3852 of needle trap 3850,through opening 3859 of the needle trap 3850, and then onto the upperside of lower structure 3852 of needle trap 3850. In this configuration,the needle receiver 3855 may present surface 3856 between adjacentneedle receiving tabs 3857 a/b for receiving a needle 3858 at the entryzone 3850 a of needle trap 3850. Through the motion of placing a needleonto surface 3856 of the needle receiver 3855 and against needlereceiving tabs 3857 a/b, and translating the needle from the entry zone3850 a through to the secure zone 3850 c of needle trap 3850, the needlereceiver 3855 translates into the needle trap 3850 and presents the nextadjacent pair of needle receiving tabs 3857 a/b and surface 3856 forsubsequent needle placement and disposal (i.e, no separate action isrequired to advance the needle receiver 3855 into the needle trap 3850).The needle receiver may prevent bunching of subsequently placed needles,may allow for easy segregation of adjacent needles, and thereby mayallow for easy needle counting.

In different embodiments, the needle trap 3850 and needle receiver 3855may have different dimension depending upon the size of the needles 3858being stored. Thus, a small needle receiver and complementary needletrap used to store small needles may have smaller dimensions than alarge needle receiver and complementary needle trap used to store largerneedles.

In many embodiments, the tip to tip distance of each of the plurality ofneedles is within a range selected from the group consisting of 75% to100% of the width of the needle slot, 80% to 99% of the width of theneedle slot, and 85% to 98% of the width of the needle slot and 90 to97% of the width of the needle slot.

In many embodiments, the tip to tip distance of each of the plurality ofneedles is within a percentage of the width of the needle slot in theexpanded configuration, the percentage within range selected from thegroup consisting of 75% to 100% of the second width of the needle slot,80% to 99% of the second width of the needle slot, and 85% to 98% of thesecond width of the needle slot and 90 to 97% of the second width of theneedle slot. The needle slot may comprise a length, a width, and aheight, the length being greater than the width and the width beinggreater than the height.

The needle receiver 3855 may be comprised of a flexible material thatallows the needle receiver to bend through the opening 3859 as shown inFIG. 385B. The needle receiver 3855 and plurality of needle receivingtabs 3857 a/b may comprise a one-piece design or multi-piece design. Ina multi-piece design, the plurality of needle receiving tabs 3857 a/bmay be comprised of a foam or rubber material, and may be adhered to thesurface 3856 of the needle receiver 3855.

The needle receiver 3855 may comprise a series of through openings toreceive a needle driver tip, the through openings located along thelongitudinal axis of the needle receiver 3855 and located betweenadjacent needle receiving tabs 3857 a/b. This series of through openingmay be sized to match the needle driver slot 3853 of the needle trap3850, such that a needle 3858 can easily be placed into the needlereceiver 3855 and translated with the needle driver from the entry zone3850 a through to the secure zone 3850 c of the needle trap 3850.

FIGS. 386A-386B illustrate an exemplary embodiment of devices 3860 and3865 for securing a plurality of needles, in accordance with manyembodiments. FIG. 386A illustrates a top view, FIG. 386B illustrates alongitudinal cross-sectional view. In the illustrated embodiment, aneedle trap 3860 may be configured according to the many embodimentsdescribed herein (e.g., as the needle trap 3850 shown in FIGS. 385A-B,with like identifiers incremented by 10). Further, in this embodiment aneedle receiver 3865 may be configured to engage a needle trap 3860according to embodiments described herein (e.g., as the needle receiver3855 engages needle trap 3850 shown in FIGS. 385A-B), and operate byconveyance. In this embodiment, needle receiver 3865 may comprise aplurality of needle receiving tabs 3857 located along the longitudinalcenterline of the needle receiver 3866 and configured to receive one ormore needles 3868.

The needle receiver 3865 may be comprised of a flexible material thatallows the needle receiver to bend through the opening 3869 as shown inFIG. 385B. The needle receiver 3855 and plurality of needle receivingtabs 3857 a/b may comprise a one-piece design, wherein the needlereceiving tabs 3857 are formed by the cutting of a pattern in the needlereceiver 3865 and bent upwards so as to receive a needle 3866. As shownin FIG. 386A, this pattern may be in the form of a backwards “C,”however any appropriate pattern may be cut so as to allow the tabs tobend upwards and receive a needle. In many embodiments, the needlereceiving tabs 3857 may deflect as the needle receiver 3865 is slidthrough the opening 3869 of needle trap 3860, but return to their bentupwards configuration afterwards so as to receive a needle 3868.

FIGS. 387A-387D illustrate longitudinal cross-sectional views ofexemplary internal spring dividers suitable for incorporation with theneedle handling systems as described herein. The internal springdividers 3871 may be configured to prevent bunching of needles 3878 uponsequential placement of needles into needle trap 3870. The internalspring dividers may each comprise a leading structure 3871 a and atailing structure 3871 b attached at a pivot structure 3871 c. Theinternal spring dividers 3871 may be rotatably attached to a lowerstructure 3872 of needle trap 3870 via a helical torsion spring orsimilar at pivot structure 3871 c. At rest, the internal spring dividers3871 may be configured such that the spring forces the leading structure3871 a against the lower structure 3872 of needle trap 3870, and therebyin position to receive a needle 3878 (as shown in FIG. 387A). As aneedle 3878 is translated into the needle trap 3870, the trailingstructure 3871 b of an internal spring divider 3871 may receive theneedle, and with continued translation of the needle into the needletrap the internal spring divider may rotate in the direction of needletranslation as the spring force is overcome, forcing the trailing edge3871 b of the internal spring divider against the lower structure 3872(as shown in FIG. 387B). With continued translation of the needle 3878,the internal spring divider may return to its resting position and anext internal spring divider 3871 may receive the needle (as shown inFIG. 387C), these actions repeated until the needle 3878 is translatedto the end of needle trap 3870. Once at the end of the needle trap 3870,the trailing structure 3871 b of the internal spring divider 3871nearest the end of the needle trap may be held against the lowerstructure 3872, as the spring of the internal spring divider may beconfigured so as not to overcome the weight of the needle (and thus notreturn the internal spring divider to its resting position). Thus, assubsequent needles 3878 are deposited into the needle trap 3870, theleading structure 3871 a of the internal spring divider 3871 nearest theend of the needle trap 3870 may block any further translation ofsubsequent needles towards the end of the needle trap. In this way, eachdeposited needle may be kept from bunching, and facilitate the easycounting of deposited needles.

FIG. 388 illustrates a longitudinal cross-sectional view of an exemplaryembodiment of a device for securing a plurality of needles, suitable forincorporation with the needle handling systems as described herein. Inthis embodiment, a needle receiver 3886 may be rolled or coiled around arotatable element and comprise a series of slits 3887 on a side of theneedle receiver opposite that of the rotatable element center. Each slit3887 may be sized so as to receive a needle 3888. Adjacent slits 3887 inthe needle receiver 3886 may be spaced apart longitudinally as necessaryaccording to the size of the needles being received. As shown in FIG.388, the needle receiver 3886 has been partially unrolled and laidagainst a structure 3880 of a needle trap of any of the embodimentsdescribed herein (structure 3880 may comprise, for example, a lowerstructure 341 of needle trap 331), such that the slits 3887 are facingtowards the structure 3880. A needle 3888 may be placed in a vacant slit3887, thereby allowing the safe disposal of the needle. Upon furtherunrolling and advancement of the needle receiver 3886 translationallyalong the surface of structure 3880, two things may occur: 1) the needleplaced in the previously vacant (but now occupied) slit 3887 may betrapped between the needle receiver 3886 and the structure 3880, and 2)the next vacant slit 3887 may be made available to receive anotherneedle. This cycle of needle disposal can be repeated as necessary todispose of needles 3888. In some embodiments, the unrolling andtranslation of the needle receiver may be performed in a single motionvia the action of depositing a needle 3888 into a slit 3887 and movingit translationally along the structure 3880. In some embodiments, theunrolling and translation of the needle receiver may be performed in twomotions: the first action being the depositing of a needle 3888 into aslit 3887; the second action being a user manually translating theneedle receiver 3886 so as to trap the deposited needle, unroll theneedle receiver, and present the next vacant slit 3887. The needlereceiver 3886 may comprise a flexible material. In some embodiments, theneedle receiver 3886 may comprise a transparent or semi-transparentmaterial. In some embodiments, the needle receiver slits 3887 may relyon the physical trapping of a needle 3888 against the structure 3880 tokeep the needle in place. In some embodiments, the needle receiver slits3887 may rely on the addition of an adhesive or other surface treatmentto aid in the physical trapping of a needle 3888. In many embodiments,the needle receiver may prevent bunching of deposited needles, andfacilitate the easy counting of deposited needles.

FIGS. 389A-389B illustrate an exemplary embodiment of a device forsecuring a plurality of needles comprising internal filaments, inaccordance with many embodiments. FIG. 389A illustrates a top view, FIG.389B illustrates a longitudinal cross-sectional view. In the illustratedembodiment, a needle trap 3890 may be configured according to the manyembodiments described herein (e.g., as the needle trap 3850 shown inFIGS. 385A-B, with like identifiers incremented by 40). A plurality ofinternal filaments 3897 may be configured to prevent bunching of one ormore needles 3898 upon sequential placement of needles into needle trap3890. The internal filaments 3897 may each be comprised of internalfilaments 3897 a and internal filaments 3897 b, which may attach to theinternal (i.e., within the needle slot 3894) surface of the upperstructure 3894 at opposing sides of the longitudinal needle driver slot3893. As shown in FIG. 389A, the internal filaments 3897 a/b may beconfigured so as to extend from their attachment points towards thecenter of the needle trap 3890 (and thus the center of the needle driverslot 3893), and form a plurality of needle receiving spaces betweenadjacent pairs of internal filaments 3897 a/b within the needle slot3894 that can complementarily receive a needle 3898. As shown in FIG.389B, the internal filaments 3897 may also be configured to extend fromtheir respective attachment points at the internal surface of the upperstructure 3894 to the internal surface of the lower structure 3892 ofneedle trap 3890 (i.e., configured to span the entire height of theneedle slot 3894).

In some embodiments, each internal filament 3897 a/b may be attachedwithin the needle trap 3893 as described above via a torsion spring, ahelical torsion spring, or similar. In these embodiments, the internalfilaments may comprise a rigid or semi-rigid material. In someembodiments, each internal filament 3897 a/b may be attached within theneedle trap 3893 as described above via an adhesive, a weld, or similarpermanent attachment. In these embodiments, the internal filaments maycomprise a flexible material capable of deforming.

At rest, the internal filaments 3897 a/b may be configured such that theends of the internal filaments opposite their respective attachmentpoints are forced down or touch against the internal surface of lowerstructure 3892 (e.g., by the force of their respective springs at theirattachment points, or by deforming, see FIG. 389B). As a needle 3898 istranslated into the needle trap 3890, the needle may abut a pair ofinternal filaments 3897 a/b, and with continued translation of theneedle into the needle trap the internal filaments 3897 a/b may deflectin the direction of needle translation to allow the needle to advancefurther into the needle trap and into a receiving space between adjacentpairs of internal filaments. The internal filaments 3987 a/b may returnto their resting position and a next pair of internal filaments 3897 a/bmay deflect with continued translation of the needle into the needletrap 3890, these actions repeated until the needle 3898 is translated tothe end of needle trap 3890. Once at the end of the needle trap 3890,the needle 3898 may hold the internal filaments 3897 a/b nearest the endof the needle trap in their resting position by inhibiting the internalfilaments from deflecting further upon subsequent translation of a nextneedle. Thus, as subsequent needles 3898 are deposited into the needletrap 3890, the needle receiving spaces between adjacent pairs ofinternal filaments 3897 a/b within the needle slot 3894 may successivelybecome occupied by a needle 3898. In this way, each deposited needle maybe kept from bunching, and facilitate the easy counting of depositedneedles.

FIGS. 390A-390E illustrate exemplary embodiments of needle driver slotcovers suitable for incorporation with the needle handling systems asdescribed herein. FIGS. 390A-390C illustrate a top view (FIG. 390A), andlateral cross-sectional views (FIGS. 390B-390C) of one exemplaryembodiment, and FIGS. 390D-390E illustrate lateral cross-sectional viewsof another exemplary embodiment. In the illustrated embodiments, aneedle trap 3900 may be configured according to the many embodimentsdescribed herein (e.g., as the needle trap 3850 shown in FIGS.385A-385B, with like identifiers incremented by 50). In the illustratedembodiments, the needle driver slot covers 3907 may be configured toslidably or rotatably attach to upper structure 3904 of needle trap 3900at one side of the needle driver slot 3903. In the illustratedembodiments, the needle trap 3900 may comprise a plurality of indicators3909 that correspond to a needle driver slot cover 3907, which mayindicate when a corresponding needle driver slot is actuated in order tofacilitate easy needle counting (e.g., by a change of indicator color).

In some embodiments (as shown in FIGS. 390A-390C), the needle slotcovers 3907 may comprise a rectangular body 3907 b slidably attached toa recess in the upper structure 3904 of needle trap 3900. Further, inthis embodiment needle slot covers 3907 may comprise a tab 3907 aattached to each rectangular body 3907 b, which may be configured tofacilitate the actuation of the needle slot cover by a surgeon (i.e.,sliding of the tab from its open position, where the needle driver slotcover 3907 does not cover the needle driver slot 3903, to its closedposition, where the needle driver slot cover 3907 does cover the needledriver slot 3903). After a needle is deposited fully into the needletrap 3900 by the surgeon, the surgeon may actuate the needle slot cover3907 directly above the deposited needle so as prevent furtherdeposition of a subsequent needle into the underlying space within theneedle trap. In this way, the needle trap covers may prevent bunching ofneedles and facilitate the counting thereof.

In some embodiments (as shown in FIGS. 390D-390E), the needle slotcovers 3907 may comprise a rectangular body 3907 b rotatably attached tothe upper structure 3904 of needle trap 3900 at rotating element 3907 c.Further, in this embodiment needle slot covers 3907 may be initiallyconfigured to be in an open state (i.e., the needle driver slot covers3907 do not cover the needle driver slot 3903). After a needle isdeposited fully into the needle trap 3900 by the surgeon, the surgeonmay actuate the needle slot cover 3907 directly above the depositedneedle by rotating the needle slot cover down over the needle driverslot 3903, allowing the end of the needle slot cover opposite therotating element to be seated into a recess in the upper structure 3904(as shown in FIG. 390E). By this action, further deposition of asubsequent needle into the underlying space within the needle trap isprevented. In this way, the needle trap covers may prevent bunching ofneedles and facilitate the counting thereof.

FIGS. 391A-391B illustrate exemplary embodiments of devices for securinga plurality of needles with a ratcheting cover, in accordance with manyembodiments. FIG. 391A illustrates a top view of an embodiment of aneedle trap with a ratcheting cover being displaced longitudinally withthe placement of a needle 3918 by a needle driver 3919, FIG. 391Billustrates a top view of the embodiment after the needle 3918 has beenplaced and the ratcheting cover has ratcheted longitudinally over thelast placed needle. In the illustrated embodiment, a needle trap 3910may be configured according to the many embodiments described herein(e.g., as the needle trap 3850 shown in FIGS. 385A-385B, with likeidentifiers incremented by 60). In the illustrated embodiment, theratcheting cover 3915 may be configured to engage the needle trap 3910at the end of the needle trap opposite the entry zone 3910 a, and coverthe upper structure 3911. In this embodiment, when needle 3918 istranslated into the far end of the needle trap 3910 with needle driver3919 through the needle driver slot 3913, the needle driver 3919 maylaterally shift the ratcheting cover 3915 in the direction of needledriver motion; upon subsequent release of the needle and removal of theneedle driver from the needle trap, the ratcheting cover may translatelongitudinally towards the entry zone 3910 a so as to cover the needlejust deposited. In many embodiments, the ratcheting cover may be aspring-loaded device, configured to translate/ratchet longitudinally inincrements according to the size of the needle 3918 being placed in theneedle trap 3910.

FIGS. 392A-392F, FIGS. 392A1-392A12, and FIGS. 392B1-392B5 illustrateexemplary embodiments of devices for securing a plurality of needles, inaccordance with many embodiments. FIG. 392A illustrates a perspectiveview of an embodiment of a needle trap, FIG. 392B illustrates aperspective view of the embodiment of a needle trap of FIG. 392A placedinside an embodiment of a second structure, FIG. 392C illustrates alateral cross-sectional view of the embodiments shown in FIG. 392B, FIG.392D illustrates a top view of the embodiment of a needle trap of FIG.392A placed inside an embodiment of a second structure, and FIGS.392E-392F illustrate lateral cross-sectional views of an embodiment of aneedle trap. FIG. 392A1 illustrates a top view of an embodiment of how aneedle trap as described herein may be constructed out of one sheet ofmaterial, and 392A2 illustrates a perspective view of an embodiment ofhow a needle trap as described herein may be constructed out of twoseparate sheets of material. FIGS. 392A3-392A4 illustrate top views ofembodiments of a needle trap. FIG. 392A5 illustrates a top view of anembodiment of a needle trap, and FIG. 392A6 shows a longitudinalcross-sectional view of the needle trap shown in FIG. 392A5. FIG. 392A7illustrates a top view of an embodiment of a needle trap, and FIG. 392A8shows a longitudinal cross-sectional view of the needle trap shown inFIG. 392A5. FIGS. 329A9-392A11 show lateral cross-sectional views of aneedle trap as described herein before, during, and after placement of aneedle into the trap. FIG. 392A12 illustrates a perspective view of anembodiment of a needle trap as described herein with internalsconfigured to aid in securing needles after being placed into the trap.

In the illustrated embodiments of FIG. 392A, FIG. 392A3, and FIG. 392B,a needle trap 3920 may be a planar device comprised of several zones: 1)an entry zone 3920 a, 2) an entryway or transition zone 3920 b and 3) asecure zone 3920 c. The needle trap 3920 may comprise an upper structure3921 and a lower structure 3922 that are securely coupled togetheraround an outer portion of the needle trap 3920. The needle trap 3920may comprise a needle driver slot 3923 extending through the upperstructure 3921, the needle driver slot configured to provide clearancefor a needle driver along the entire length of needle translation fromentry zone 3920 a to secure zone 3920 c. The needle trap 3920 mayfurther comprise a needle slot 3924 that constrains the secured needlesinto a single needle depth array, to minimize overall depth profile andfacilitate needle counting. The configuration of the needle trap 3920can be described with reference to an X-axis, Y-axis, and Z-axis asshown in FIG. 392A.

In an embodiment, the entry zone 3920 a of the needle trap 3920 maycomprise a partially rectangular flat zone or area in the X-Y plane thatis an exposed part of the lower structure 3922. A surgeon can hold usedneedles 3928 with a needle driver and place the used needles 3928 on anupper surface of the entry zone 3922 (i.e., surface in the positiveZ-axis). The contact and/or force of the needle 3928 against the entryzone 3928 may cause the curvature of the used needle 3928 to be movedinto a planar orientation flat against the entry zone upper surface inthe X-Y plane with the convex mid-portion of the curved needle 3928facing or pointing towards the transition zone 3920 b.

The entry zone 3920 a may be the same width (Y-axis) relative to needleslot 3924 and the perimeter around the entry zone 3920 a may have acontrasting color to aid visual recognition. The upper surface of theentry zone 3920 a may comprise a low friction material. The uppersurface of the entry zone 3920 a may include graphic guides to indicateproper needle orientation to the surgeon. The entry zone 3920 a may befolded over upper structure 3921 to secure needles deposited within theneedle trap 3920.

The transition zone 3920 b may be disposed between the entry zone 3920 aand the secure zone 3920 c. In some embodiments, in the transition zone,edges 3925 of the upper structure 3921 where the upper structureintersects with the needle driver slot 3923 at the entry zone/transitionzone may be folded inward into the needle slot 3924 as shown in FIG.392A5-392A6. In a folded inward configuration, edges 3925 may increasethe depth (Z-axis) of the needle slot at the entry zone/transition zoneintersection and facilitate loading of needles into the needle trap, asexemplified in the longitudinal cross-sectional view of FIG. 392A6.Additionally, the inward-folded edges 3925 may prevent needles 3928 fromexiting back out of the needle trap 3920 by blocking any egress (e.g.,the inward folded edges may catch the needles). In the transition zone,the compressive side load on the needles ends may be increased and theheight (Z-axis) of the needle slot may be decreased as the securedneedles are translated through the transition zone, thus constrainingthe needles to a single needle deep array extending longitudinally alongthe secure zone 3920 c. In some embodiments, in the transition zone,edges 3925 of the upper structure 3921 where the upper structureintersects with the needle driver slot 3923 at the entry zone/transitionzone may be folded outward as shown in FIG. 392A7-392A8. In a foldedoutward configuration, edges 3925 may help guide a needle driver intothe needle driver slot 3923. In some embodiments, edges 3925 may not befolded, and the height (Z-axis) of the needle slot 3924 may remainconstant from the transition zone 3920 b through the secure zone 3920 c.In some embodiments, the width (Y-axis) of the entry zone 3920 a,transition zone 3920 b, and secure zone 3920 c may be the same.

The secure zone 3920 c may be disposed adjacent the transition zone 3920b, and comprise the region in which full compressive side loading isapplied to the needle ends to prevent unintentional removal ordislodging of the needles 3928.

The needle trap 3920 may be configured to promote needles, upon entry,to assume an orientation where the convex side of the needle 3928 facesthe secure zone 3920 c, and the concave side, sharp point, and tail ofthe needle 3928 face the entry zone 3920 a. Thus, the needle trap 3920may be configured to have the sharp point and tail end of the needle3928 pointing away from the direction of motion, thereby reducing therisk of needle-stick injury. The needle driver slot 3923 may intersect aportion of the needle slot 3924, such as a middle portion of the needleslot, and may be disposed in the midline of the needle trap 3920 in theX-axis such that the distal tip of the needle driver can translate theneedle 3928 along the X-axis of the needle trap 3920. Alternatively, theneedle driver slot 3923 may intersect the needle slot 3924 off themidline or asymmetrically, such that the needle driver slot extendsalong an axis substantially parallel to, but not overlapping, the X-axisof the needle trap 3920. The needles 3928 may slide/translate within theneedle slot 3928 deeper into the secure zone 3920 c (i.e., away from theentry zone 3920 a) without excessive resistance or sensitivity as to howthe needles 3928 are grasped by the needle holder. In an embodiment, thesecure zone 3920 c can prevent used needles 3928 from being removed fromthe needle trap 3920.

In a preferred embodiment, the needle 3928 is moved into contact withthe entry zone 3920 a of the lower structure 3922 by the surgeonmanipulating the tip of the needle driver holding the needle. The needle3928 can be pushed against the entry zone 3920 a and become aligned withthe X-Y plane of the needle trap 3920. The needle 3928 can then be movedin translation along the longitudinal X-axis of the needle trap 3928from the entry zone 3920 a into the transition zone 3920 b where theneedle 3928 slides into the needle slot 3924 with the convex side facingthe secure zone 3920 c and the sharp point and tail of the needle 3928facing the entry zone 3920 a. The needle driver can be translated tomove the needle 3928 into the needle slot 3924 in the secure zone 3920 cuntil the needle driver runs into the end of the needle slot 3924 or thelast inserted used needle 3928.

In some embodiments, the needle driver slot 3928 may comprise a linearcut through the upper and lower surfaces of the upper structure 3921 asexemplified in FIG. 392A3. In these embodiments, inherent flexibility ofthe needle trap material may allow the linear edges of the needle driverslot to deform and allow translation of the needle driver. In someembodiments, the needle driver slot 3928 may comprise a width in theY-axis configured to receive the distal tip of the needle driver holdinga needle 3928. In these embodiments, this width may narrow in the securezone 3920 c so that the distal tip of a needle driver with an elongatedcross section must orient with the needle driver slot 3923 such that theheld needle 3928 is properly aligned across the width of the secure zone3920 c within the needle trap 3920. In some embodiments, the needledriver slot 3928 may comprise a width in the Y-axis that is constantthroughout its length in the X-axis, as exemplified in FIG. 392A4.

In many embodiments, the needle trap 3920 comprises a deformable,flexible, and/or compliant material. In many embodiments, the needletrap 3920 comprises a deformable, flexible, and/or compliant materialthat can provide compressive force to secure the one or more needles3928 within the needle slot 3924. Alternatively or in combination, andas exemplified in FIG. 392A12, the needle trap 3920 may comprisemagnetic strips, foam, surface coatings, gel, and the like identified as3924 a within the needle slot 3924 as described herein to preventneedles from exiting the envelope.

In many embodiments, and as shown in FIG. 329A9, needle trap 3920 mayassume a planar configuration wherein the lower surface of upperstructure 3921 and the upper surface of the lower structure 3922 restagainst one another without the presence of any needles in the needleslot 3924 (i.e., without needles in the needle trap, the needle traplays flat against its mounting surface). As shown in FIG. 329A10, as aneedle 3928 is loaded into the needle trap 3920 through needle slot 3924by the needle driver 327, the inherent flexibility of the needle trapmaterial may allow the edges 3925 of the upper structure 3921, thelinear edges of the needle driver slot 3923 of the upper structure 3921,and the upper structure 3921 to deform and conform to the needle 3928and needle driver 327 as the needle driver 327 holding needle 3928 istranslated into the needle trap 3920 for placement of needle 3928. Asshown in FIG. 392A11, after the needle 3928 has been placed into theneedle slot 3924 of the needle trap 3920, the inherent flexibility ofthe needle trap material may allow the edges 3925 of the upper structure3921, the linear edges of the needle driver slot 3923 of the upperstructure 3921, and the upper structure 3921 to conform to the needle3928. In some embodiments, the conforming of the edges 3925 of the upperstructure 3921, the linear edges of the needle driver slot 3923 of theupper structure 3921, and the upper structure 3921 may apply acompressive force to the needle 3928 within the needle trap 3920,thereby securing needle 3928 in place. In some embodiments, theconforming of the edges 3925 of the upper structure 3921, the linearedges of the needle driver slot 3923 of the upper structure 3921, andthe upper structure 3921 may be limited to the location of the needle3928 (i.e., remote from needle 3928, the lower surface of upperstructure 3921 and the upper surface of the lower structure 3922 restagainst one another). In some embodiments, the lower structure 3922 mayadditionally deform and conform to the needle 3928. In some embodiments,the lower structure 3922 may additionally deform and conform to theneedle 3928 and needle driver 327.

In many embodiments, the needle trap 3920 may comprise a deformable,flexible, and/or compliant material that can prevent the one or moreneedles 3928 from puncturing through the lateral and longitudinal wallsof the needle trap (i.e., puncture resistant material). The thickness ofthe material used to construct the needle trap 3920 may be in the rangeof 0.008 inches to 0.030 inches. The material used to construct theneedle trap 3920 may comprise PTFE, Tyvek, polycarbonate, polyamide,Kevlar, PVC, and PETG; preferably PETG. The material used to constructthe needle trap 3920 may have a puncture resistance of with strength toresist puncture with a sharp tip of a needle with at least 0.3 poundforce applied to the tip of the needle, wherein the needle is a UnitedStates Surgical Corporation GS-21 needle or to resist puncture with asharp tip of a needle with at least 0.3 pound force applied to the tipof the needle, wherein the needle is a United States SurgicalCorporation CV-23 needle, or to resist puncture with a sharp tip of aneedle with at least 0.3 pound force applied to the tip of the needle,wherein the needle is a United States Surgical Corporation thin bodiedhalf-circle needle, or to resist puncture with a sharp tip of a needlewith at least 0.3 pound force applied to the tip of the needle, whereinthe needle is a United States Surgical Corporation medium bodiedhalf-circle needle, or to resist puncture with a sharp tip of a needlewith at least 0.5 pound force applied to the tip of the needle, whereinthe needle is a United States Surgical Corporation GS-21 needle, or toresist puncture with a sharp tip of a needle with at least 0.5 poundforce applied to the tip of the needle, wherein the needle is a UnitedStates Surgical Corporation CV-23 needle, or to resist puncture with asharp tip of a needle with at least 0.5 pound force applied to the tipof the needle, wherein the needle is a United States SurgicalCorporation thin bodied half-circle needle, or to resist puncture with asharp tip of a needle with at least 1 pound force applied to the tip ofthe needle, wherein the needle is a United States Surgical Corporationmedium bodied half-circle needle, to resist puncture with a sharp tip ofa needle with at least 1 pound force applied to the tip of the needle,wherein the needle is a United States Surgical Corporation GS-21 needle,or to resist puncture with a sharp tip of a needle with at least 1 poundforce applied to the tip of the needle, wherein the needle is a UnitedStates Surgical Corporation CV-23 needle, or to resist puncture with asharp tip of a needle with at least 1 pound force applied to the tip ofthe needle, wherein the needle is a United States Surgical Corporationthin bodied half-circle needle, or to resist puncture with a sharp tipof a needle with at least 1 pound force applied to the tip of theneedle, wherein the needle is a United States Surgical Corporationmedium bodied half-circle needle, or to resist puncture with a sharp tipof a needle with at least 3 pound force applied to the tip of theneedle, wherein the needle is a United States Surgical Corporation GS-21needle, or to resist puncture with a sharp tip of a needle with at least3 pound force applied to the tip of the needle, wherein the needle is aUnited States Surgical Corporation CV-23 needle, or to resist puncturewith a sharp tip of a needle with at least 3 pound force applied to thetip of the needle, wherein the needle is a United States SurgicalCorporation thin bodied half-circle needle, or to resist puncture with asharp tip of a needle with at least 3 pound force applied to the tip ofthe needle, wherein the needle is a United States Surgical Corporationmedium bodied half-circle needle.

In different embodiments, the needle trap 3920 may have differentdimensions depending upon the size of the needles 3928 being stored.Thus, a small needle trap used to store small needles may have smallerdimensions than a large needle trap used to store larger needles.Needles may include the needles sizes listed above or other availableneedles, such as surgical needles available from United States SurgicalCorporation.

In some embodiments, the needle trap 3920 may be constructed out of onesheet of material as shown in FIG. 392A1. In these embodiments, theneedle driver slot 3923 may be cut through the needle trap 3920 anddimensioned as described herein (e.g., the needle driver slot maycomprise a single cut, forming a linear cut through the material, or maycomprise a through cut with a width 3923 b as shown herein). Further,the single sheet of material may be folded over on itself and the outerperimeter along the longitudinal axis of the needle trap may be sealedso as to create the needle trap 3920 with a needle slot 3924 bounded byclosed-in walls as described herein. In some embodiments the needle trap3920 may be constructed out of two separate sheets of material as shownin FIG. 392A2. In these embodiments, the needle driver slot 3923 may becut through one sheet of material that will form the upper structure3921 of the needle trap 3920 (i.e., the top sheet shown in FIG. 392A2)and dimensioned as described herein (e.g., the needle driver slot maycomprise a single cut, forming a linear cut through the material, or maycomprise a through cut with a width 3923 b as shown herein). Further,this one sheet of material that will form the upper structure 3921 maythen be adhered to another sheet of material that will form the lowerstructure 3922 of the needle trap 3920 (i.e., the bottom sheet shown inFIG. 329A2) so as to seal the outer perimeter along the longitudinalaxis of the needle trap and the lateral perimeter of the needle trapopposite the entry zone. In many embodiments, sealing the outerperimeter may comprise the use of an adhesive, a glue, a weld, a stitch,or any other joining means.

In some embodiments, the lower surface of lower structure 3922 of needletrap 3920 may comprise adhesive, velcro, or other bonding means toreleasably attach the needle trap 3920 to a mounting surface, such asthe barrier mounting base, barrier, or base as described herein. In someembodiments, the lower surface of lower structure 3922 of needle trap3920 may comprise adhesive, or other bonding means to permanently attachthe needle trap 3920 to a surface.

In some embodiments, the needle trap 3920 as described herein may beplaced/inserted into a re-usable secondary structure 3926 (as shown inFIGS. 392B-392D and FIGS. 392B1-392B5) configured to receive the needletrap 3920. The secondary structure 3926 may comprise an upper structure3926 a, a lower structure 3926 b, a needle driver slot 3926 d, a needletrap receiving slot 3926 e, and a lateral wall 3926 c (which may joinupper structure 3926 a to lower structure 3926 b at the lateralperimeter of secondary structure 3926 at the end opposite the needletrap receiving slot 3926 e). The secondary structure may also compriseone or more longitudinal walls 3926 f (which may join upper structure3926 a to lower structure 3926 b at the longitudinal perimeters of thesecondary structure 3926). Alternatively or in combination, thesecondary structure may also comprise inner grooves 3926 g configured toreceive the needle trap 3920.

The needle trap receiving slot 3926 e of the secondary structure 3926may be configured so as to receive the needle trap 3920. Thus, indifferent embodiments, the secondary structure may have differentdimensions depending upon the size of the needle trap 3920. The fit ofthe needle trap 3920 within the needle trap receiving slot 3926 e may beloose or tight, and rely on friction or surface treatments to accomplishthe desired fit. In some embodiments, the secondary structure provides acompressive force to the needle trap within.

The needle driver slot 3926 d of the secondary structure 3926 may beconfigured to match the dimensions of the needle driver slot 3923 of theneedle trap 3920. Alternatively, the needle driver slot 3926 d may beoversized (i.e., has greater width in the Y-axis) than the needle driverslot 3923.

The lateral wall 3926 c of the secondary structure 3926 may serve as astop for the needle trap 3920 (i.e., the needle trap is fullyseated/inserted into the secondary structure when the needle trap abutsthe lateral wall). Optional longitudinal walls 3926 f may additionallyserve to constrain the needle trap 3920 from lateral movement duringuse.

In some embodiments, the needle driver slot 3926 d of the secondarystructure 3926 may extend through both the upper structure 3926 a (asshown in FIGS. 392B-392D) and the lower structure 3926 b (as shown inFIG. 392B1). Configured as such, the distal end of the needle driver isallowed to traverse the entire height (Z-axis) of the secondarystructure, which may facilitate depositing of needles 3928 into needletrap 3920.

In further detail the secondary structure 3926 of FIG. 392B1 may includea first stiff member 3926 j having first and second ends and a secondstiff member 3926 h extending from the first end of the first stiffmember and third stiff member 3926 i extending from the second end ofthe first stiff and in a same plane as the second stiff member 3926 h.The stiff structure 3926 may be configured to receive a needlereceptacle 3920 of any of the preceding claims between the second andthird stiff members 3926 h, 3926 i.

In some embodiments, the distance 3926 d between the second and thirdmembers 3926 h, 3926 i at an end proximate the first member 3926 j isless than a distance 3926 k between the second and third member 3926 h,3926 i at a distal end such that when the needle receptacle is receivedwithin the stiff structure, the second and third members impart a force,such as a lateral compressive force on the needle receptacle 3920,deforming the needle receptacle and enlarging an entry to the needleslot of the needle receptacle.

As shown in FIGS. 392E-392F, in some embodiments the needle trap 3920may comprise one or more longitudinal runners 3927 adhered to the bottomof lower structure 3922. In some embodiments, the longitudinal runnersmay be configured to provide a needle driver space 3929 defined by thespace between the bottom of the needle trap 3920, the adjacent verticalsurfaces of the longitudinal runners 3927, and the barrier surface ofwhich the needle trap is attached. In some embodiments, the longitudinalrunners 3920 may be sized so as to span the length of the needle trapcomprised of the secure zone 3920 c and the transition zone 3920 b. Insome embodiments, the longitudinal runners 3920 may be comprised of afoam, rubber, or rigid material.

In many embodiments, the longitudinal runners 3927, by providing needledriver space 3929, allow for the distal tip of the needle driver todeflect the lower structure 3922 of needle trap 3920 downward (as shownin FIG. 392F) so as to facilitate translation of needle 3928 into theneedle trap. In some embodiments, only one longitudinal runner 3927 maybe adhered to the underside of the needle trap 3920, and a needle 3928is loaded into the needle with compliance of the needle trap material.

In some embodiments, the needle trap 3290 and the secondary structure3926 may be configured to provide a compressive lateral force on theneedle trap 3290 so as to promote spreading open of the needle slot 3924(i.e., to facilitate easy placing of needles into the needle trap).FIGS. 392B2-392B3 and FIGS. 392B4-392B5 illustrate exemplary embodimentsof such configurations. In these exemplary embodiments, the needle trap3290 may have a lateral width 3920 d at the end of the needle trapopposite the needle slot 3924, and a lateral width 3920 k at the needleslot 3924. Further, in these exemplary embodiments, the inner grooves3926 g of the secondary structure 3926 may have an inner lateral width3926 d within the secondary structure opposite the needle trap receivingslot 3926 e entrance, and an inner lateral width 3926 k at the entranceof the needle trap receiving slot 3926 e. In the embodiments shown inFIGS. 392B2-392B3, the inner lateral widths 3926 d and 3926 e of thesecondary structure 3926 may be the same, while the lateral width 3920 dof the needle trap may be less than the lateral width 3920 k of theneedle trap 3290. Further, the lateral widths 3926 d and 3926 e of thesecondary structure may be sized complementarily to the lateral width3920 d of the needle trap 3290. Thus, the lateral width 3920 k of theneedle trap 3920 is greater than the lateral widths 3926 d and 3926 e ofthe secondary structure. Dimensioned as such, when the needle trap 3290is placed into the secondary structure 3926, the secondary structure3926 may provide a compressive lateral force on the needle trap 3290 soas to promote spreading open of the needle slot 3924, as shown in FIG.392B3. Alternatively, in the embodiments shown in FIGS. 392B4-392B5, thelateral widths 3920 d and 3920 k of the needle trap 3290 may be thesame, while the inner lateral width 3926 k of the secondary structuremay be less than the inner lateral width 3926 d of the secondarystructure 3296. Further, the inner lateral width 3926 d of the secondarystructure 3926 may be sized complementarily to the lateral width 3920 dof the needle trap 3290. Thus, the inner lateral width 3296 k of thesecondary structure is less than the lateral widths 3920 d and 3920 k ofthe needle trap 3290. Dimensioned as such, when the needle trap 3290 isplaced into the secondary structure 3926, the secondary structure 3926may provide a compressive lateral force on the needle trap 3290 so as topromote spreading open of the needle slot 3924, as shown in FIG. 392B5.In some embodiments, the lateral dimensions 3920 d and 3920 k of theneedle trap, and inner lateral dimensions 3926 d and 3926 k of thesecondary structure, may be configured as necessary to provide acompressive lateral force on the needle trap 3290 so as to promotespreading open of the needle slot 3924.

FIGS. 393A-393B illustrate an exemplary embodiment of a device 3930 forsecuring a plurality of needles, in accordance with many embodiments.The device 3930 comprises a u-shaped housing 3931 having an upperportion 3932 and a lower portion 3933 coupled together by a hingeportion 3934 at the back end of the housing. The space, or cavity,between the upper portion and the lower portion forms a planar needleslot 3935 for storing a plurality of needles N. The hinge portion 3934may be spring-loaded to bias the upper and lower portions of the housingtowards one another, such that the needles can be secured within theneedle slot by the compressive forces exerted by the upper and lowerportions. Each of the upper portion and the lower portion comprises afirst arm and a second arm, wherein the space between the first arm andthe second arm defines a needle driver channel or slot 3936 extendingdown the center of the “U”. In use, the tip of a needle driver holding aneedle may be aligned with the needle driver slot 3936, and the needlealigned with the planar needle slot 3935, and then the needle driver tipmay be translated along the needle driver slot towards the hinge portionof the housing to secure the needle within the needle slot.

Optionally, the lower portion of the housing may comprise an extendedportion 3937 that extends beyond the front end of the upper portion ofthe housing. In use, the extended portion 3937 can provide a landingzone for a needle to be secured in the device, wherein the needle may beplaced in contact with the upper surface of the extended portion withthe needle driver tip aligned with the needle driver slot. The landingzone can facilitate the insertion of the needle into the needle slot byeliminating the need for a user to carefully align the needle with theplane of the needle slot. Optionally, the housing may further compriseblocking tabs 3938 a, 3938 b located at the front end of the housing,extending from the front outer edge of the lower housing portion to thefront outer edge of the upper housing portion. The blocking tabs canprevent a needle from entering the needle slot with one or both ends ofthe needle exposed beyond the arms of the u-shaped housing, thusreducing the risk of needle stick injury by ensuring that both ends ofthe needle are secured between the upper and lower portions of thehousing.

Optionally, to further reduce the risk of an exposed needle endextending beyond the arms of the u-shaped housing 3931, the device 3930may be provided with lateral walls 3939 disposed over the outer lateraledges of the u-shaped housing, as shown in FIG. 393B. The lateral walls3939 may be integrated portions of the housing 3931, or they may beprovided a separate accessory that can be removably coupled to thedevice 3930. For example, the device 3930 may be provided with au-shaped accessory comprising the lateral walls 3939 and dimensioned tofit closely over the outer edges of the housing 3931.

FIG. 394 illustrates an exemplary embodiment of a device 3940 forsecuring a plurality of needles, in accordance with many embodiments.The device 3940 comprises a housing 3941 having an upper portion 3942and a lower portion 3943 coupled together by a hinge portion 3944 at theback end of the housing. The space between the upper and lower portionsforms a planar needle slot 3945 for storing a plurality of needles N.The hinge portion 3944 may be spring-loaded to bias the upper and lowerportions towards each other, such that the needles can be secured withinthe needle slot by the compressive forces exerted by the upper and lowerportions of the housing. The upper portion may define an upper needledriver slot 3947 a extending along the length of the housing andconfigured to allow translation of a needle driver tip therein. Thelower portion may define a lower needle driver slot 3947 b substantiallyaligned with the upper needle driver slot. Further, the lower portioncomprises an extended portion 3948 that extends beyond the front end ofthe upper housing portion, to provide a landing zone for the needle tobe placed into the device. The lower needle driver slot 3947 b canextend into the extended portion, as shown. In use, a needle driverholding a needle may be placed over the extended portion with the tip ofthe needle driver aligned with the front end of the lower needle driverslot 3947 b and the needle contacting the upper surface of the extendedportion. Subsequently, the needle driver tip may be translated along theupper needle driver slot towards the back end of the device, to securethe needle within the needle slot. The landing zone can facilitate theinsertion of the needle into the needle slot by eliminating the need fora user to carefully align the needle with the plane of the needle slot.

FIG. 395 illustrates an exemplary embodiment of a device 3950 forsecuring a plurality of needles, in accordance with many embodiments.The device 3950 may be similar in many aspects to the device 3510 shownand described in reference to FIGS. 351A-351C, and the device 3940 shownand described in reference to FIG. 394. The device 3950 comprises ahousing 3951 having an upper portion 3952 and a lower portion 3953movably coupled to one another by a hinge portion 3954 at the back endof the housing. The space between the upper portion and the lowerportion forms a planar needle slot (best seen in FIG. 351C, slot 3515)for storing a plurality of needles N. The upper portion 3952, lowerportion 3953, and hinge portion 3954 may be similar in many aspects tothe correspondingly named elements of the device 3940 described inreference to FIG. 394. The upper portion may further include lateralwalls 3955 configured to capture and enclose the ends of the needlesdisposed within the needle slot, thereby reducing the risk of needlestick injury from an exposed needle end extending beyond the lateralsides of the housing.

FIG. 396 illustrates an exemplary embodiment of a device 3960 forsecuring a plurality of needles, in accordance with many embodiments.The device 3960 comprises a first clip 3961 a and a second clip 3961 b,also referred to as elongated members. Each clip having a respectiveslot 3962 a and 3962 b shaped to receive ends of a plurality of needlesN. The clips may be formed from and/or include spring materialsconfigured to apply compressive force against the ends of the needlesdisposed within the slots in order to secure the needles in place withthe tips of needles covered. The two clips are aligned and arranged withthe openings of the slots facing each other, such that a needle N may beinserted into the device with one end of the needle entering the slot ofthe first clip, and the other end entering the slot of the second clip,with the needle in a substantially planar orientation with respect tothe plan of the device 3960. The first clip and the second clip may bespaced apart to define a needle driver slot 3963 between the two clips,wherein the tip of a needle driver holding a needle may be translatedalong the needle driver slot to secure the needle within the device. Thedevice may further comprise a back wall 3964 disposed across the backend of the device to block the back end of the first and second clips,to prevent a user from accidentally translating the needle driverholding the needle beyond the back end of the device. The back wall 3964may be provided as an integral portion of the device, or it may beprovided as a separate component that may be coupled to the two clipsbefore use, for example via adhesives or mechanical fasteners.

FIGS. 397A-397B illustrate exemplary embodiments of a device fordispensing and securing a plurality of needles, in accordance with manyembodiments. FIGS. 397A and 397B both illustrates top views of exemplaryembodiments of a needle trap 3970 wherein a lateral side 3972 of theneedle trap is not enclosed. Needle trap 3970 can be as per any of theneedle trap embodiments as described herein. In the exemplaryembodiments shown, a plurality of unused needles 103 may be providedwithin the needle trap 3970 in a new needle secure zone near the lateralend 3972 that is not enclosed, allowing unused needles 103 to be grabbedand translated out of the open lateral end 3972, also referred to as anexit, for use. Further, one or more needles 104 may be placed into theneedle trap 3970 with a needle driver through needle driver slot 3973and a needle slot as described in the many embodiments of needle trapsherein. As shown in FIG. 397A the needle driver slot 3973 may be formedthrough the upper structure and extending from the perimeter of theupper structure at a first end to the perimeter of the upper structureat a second end. In this way, the needle trap 3970 may be both a needledispenser and a needle trap. As shown in FIG. 397A, in some embodiments,new needles may be separated from used needles by one or more stops 3971located within the needle driver slot 3973 or needle slot. The one ormore stops may comprise one or more raised surfaces that can inhibittranslation of a needle driver holding a used needle 104 fromtranslating past the one or more stops, thereby separating a used needlesecure zone having used needles 104 from new needle secure zone havingunused needles 103. Alternatively or in combination, the one or morestops may comprise surface treatments than increase friction between aused needle 104 and the complementary needle slot so as to preventtranslation of used needles 104 into unused needles 103. In someembodiments, the needle driver slot 3973 may comprise a lateral bridge(i.e., the needle driver slot is not continuous) so as to blocktranslation of a needle driver holding used needles 104, and thusprevent translation of used needles 104 into unused needles 103. Asshown in FIG. 397B, in some embodiments, no needle stops may beprovided. In some embodiments, needle trap 3970 may be configured with adecrease in the height of the needle slot to prevent translation of usedneedles 104 into unused needles 103.

FIGS. 398A-398D illustrate exemplary embodiments of a barrier mountingbase with a needle dispenser and needle trap mounted to a barrier fordispensing and securing a plurality of needles, in accordance with manyembodiments. FIG. 398A illustrates a top view of a barrier mounting base3693 with a needle dispenser 101 containing needles 103 and with aneedle trap 331 mounted thereto, and this assembly mounted to a barrier403 donned by a surgeon, as described herein. FIGS. 398B-398D illustrateend views of exemplary embodiments of barrier mounting base 3693 and howit may interact with the barrier 403 when coupled thereto.

As shown in FIGS. 398B-398D, and in accordance with many embodimentsdescribed herein, the barrier mounting base 3693 may serve as thesubstrate for mounting devices such as needle dispenser 101. Asdescribed herein, the barrier mounting base 3693 may comprise anymaterial capable of providing sufficient rigidity to stably supportdevices such as the needle dispenser 101 while coupled to the barrier403 at a mating surface 3982, the mating surface 3982 defined as thearea where the underside of the barrier mounting base 3693 couples tothe external/exposed surface of the barrier 403. Also as describedherein, adhesive members, magnetic couplings, velcro attachments,mechanical coupling mechanisms such as a snap-fit, or other couplingmechanisms may be used to couple the barrier mounting base 3693 to thebarrier 403 at mating surface 3982. In many embodiments, and as shown inFIG. 398B, the barrier mounting base 3693 may be configured to resisttorsion and/or bending, such that when coupled to the barrier 403 atmating surface 3982, gaps 3980 between the barrier mounting base 3693and barrier 403 may be present. In some embodiments, and as shown inFIG. 398C, the underside of the barrier mounting base 3693 may compriseone or more extensions 3981 that may span all or part of the gapsbetween the underside of the barrier mounting base 3693 and theexternal/exposed surface of the barrier 403, thus acting to addtorsional stability to the barrier mounting base 3693 when coupled tothe barrier 403. The extensions 3981 may comprise foam, rubber, or anyother material capable of conforming to the external/exposed surface ofthe barrier 403. The extensions 3981 may be configured as necessary toadd torsional stability to the barrier mounting base 3693 when coupledto the barrier 403 and thereby be torsional stiffeners. In someembodiments, and as shown in FIG. 398D, the barrier mounting base 3693may be configured with a concave underside dimensioned to complement theconvex external/exposed surface of the barrier 403 and receive a barriertherein. In these embodiments, the mating surface 3982 may be maximized,thus acting to maximize torsional stability to the barrier mounting base3693 when coupled to the barrier 403. In some embodiments, a lowersurface of the barrier mounting base contacts a curved surface of thebarrier at a first location and the first and second extensions contactthe curved surface of the batter at respective second and thirdlocations.

FIGS. 399A-399D illustrate exemplary embodiments of a device fordispensing one or more swaged needles, in accordance with manyembodiments. FIG. 399A illustrates a perspective view of an embodimentof a swaged needle dispenser 3990 for dispensing a swaged needle 103,and FIGS. 399B-399D illustrate cross-sectional views of exemplaryembodiments of posts 3992, also referred to as couplings or extensions,and post receivers 3995, also referred to as couplings, of swaged needledispenser 3990.

In the illustrated embodiments of FIGS. 399A-399D, a swaged needledispenser 3990 may be a substantially planar device for dispensing oneor more swaged needles 103, comprising a planar base 3991, two or moreposts 3992 disposed on the upper surface of the planar base 3991, two ormore post receivers 3995 disposed on the lower surface of the planarbase 3991, and one or more swaged needle receivers 3993 disposed on theupper surface of the planar base 3991. In some embodiments, the posts3992 and post receivers are part of a spindle. The swaged needledispenser 3990 may be configured as shown in FIG. 399A, wherein posts3992 are disposed along the outer perimeter of the planar base 3991, andthe needle receiver 3993 is disposed at the center of the planar base3991, post receivers 3995 may be disposed on the underside of the planarbase 3991 at locations matching the posts 3992). Also as shown in FIG.399A, a swaged needle 103 may be held by the needle receiver 3993, andsuture 3994 coupled to the swaged needle 103 wrapped around posts 3992.Posts 3992 may comprise a head 3992 b attached to a neck 3992 a, whereinthe neck 3992 a attaches to the planar base 3991. Post heads 3992 b maycomprise one or more slots 3992 c recessed into the heads, which mayserve to receive the terminal end of suture 3994.

In many embodiments, and as exemplified in FIGS. 399B-399D, posts 3992may comprise a neck 3992 a with a height 3992 i, and a head with height3992 h and width 3992 w. Further, post receivers 3995 (couplings) maycomprise a height 3992 y and width 3992 x that are complementarilydimensioned so as to receive post heads 3992 c upon stacking of two ormore swaged needle dispensers 3990. The heights 3992 i and 3992 h ofpost 3992 neck 3992 a and head 3992 b may be configured as necessary toaccept suture 3994 when wrapped therearound. In preferred embodiments,height 3992 h may be less than or equal to 1 centimeter. The heads ofposts 3992 may be configured in many different ways and comprise acircular, square, oval, rectangular, multi-faceted, or othercross-sectional shape. As shown in FIG. 399B, the head of post 3992 maybe configured with a step in. As shown in FIG. 399C, the head of post3992 may be configured with a shoulder or step out so as to aid inretention of suture 3994 when wrapped. As shown in FIG. 399D, the headof post 3992 may be configured to flare out so as to aid in retention ofsuture 3994 when wrapped.

The planar base 3991, two or more posts 3992, and two or more postreceivers 3995 may comprise any material suitable to provide a rigid orsemi-rigid swaged needle dispenser 3990, for example plastic, metal, orsimilar. In many embodiments, the swaged needle dispenser 3990 comprisesmaterials capable of being sterilized.

The planar base 3991 of swaged needle dispenser 3990 may comprise anyshape desired, and with any number of posts 3992, post receivers 3995,and needle receivers 3993 as necessary to hold any number of swagedneedles 103 with attached sutures 3994. For example, the planar base3991 may assume a circular, square, oval, rectangular, multi-faceted, orany other shape. In many embodiments, two or more swaged needledispensers may be stacked upon one another.

FIGS. 400A-400D illustrate exemplary embodiments of a device fordispensing one or more swaged needles, in accordance with manyembodiments. FIG. 400A illustrates a perspective view of an embodimentof a swaged needle dispenser 4000 for dispensing one or more swagedneedles 103, and FIGS. 400B-400D illustrate cross-sectional views ofexemplary embodiments of posts 4002 of swaged needle dispenser 4000.

In the illustrated embodiments of FIGS. 400A-400D, a swaged needledispenser 4000, also referred to as a housing, may be a substantiallyplanar device for dispensing one or more swaged needles 103, comprisinga planar base 4001, two or more posts 4002, also referred to asspindles, disposed on the upper surface of the planar base 4001, alsoreferred to as a bottom portion, and one or more swaged needle receivers3993 disposed on the upper surface of the planar base 4001 and couplingthe swaged needle to the swaged needle dispenser. The swaged needledispenser 4000 may be configured as shown in FIG. 400A, wherein posts4002 are disposed in pairs along the opposite sides of the planar base4001, and the needle receiver 3993 is disposed at the center of theplanar base 3991 between opposing posts 4002. Configured in this way,swaged needles 103 may be stored by the swaged needle dispenser 4000 inan array. Also as shown in FIG. 400A, a swaged needle 103 may be held bythe needle receiver 3993, and suture 3994 coupled to the swaged needle103 wrapped around opposing pairs of posts 4002. Posts 4002 may comprisea head 4002 b attached to a neck 4002 a, wherein the neck 4002 aattaches to the planar base 4001. Post heads 4002 b may comprise one ormore slots 4002 c recessed into the heads, which may serve to receivethe terminal end of suture 3994.

In many embodiments, and as exemplified in FIGS. 400B-400D, posts 4002may comprise a neck 4002 a with a height 4002 i, and a head with height4002 h and width 4002 w. The heights 4002 i and 4002 h of post 4002 neck4002 a and head 4002 b may be configured as necessary to accept suture3994 when wrapped therearound. In preferred embodiments, height 4002 hmay be less than or equal to 1 centimeter. The heads of posts 4002 maybe configured in many different ways and comprise a circular, square,oval, rectangular, multi-faceted, or other cross-sectional shape. Asshown in FIG. 400B, the head of post 4002 may be configured with arounded top and flat bottom (e.g., like a mushroom) so as to aid inretention of suture 3994 when wrapped. As shown in FIG. 400C, the headof post 4002 may be configured with a rounded top and bottom so as toaid in retention of suture 3994 when wrapped. As shown in FIG. 400D, thehead of post 4002 may be configured with a flat top and bottom so as toaid in retention of suture 3994 when wrapped.

The planar base 4001 and two or more posts 4002 may comprise anymaterial suitable to provide a rigid or semi-rigid swaged needledispenser 4000, for example plastic, metal, or similar. In manyembodiments, the swaged needle dispenser 4000 comprises materialscapable of being sterilized.

The planar base 4001 of swaged needle dispenser 4000 may comprise anyshape desired, and with any number of posts 4002 and needle receivers3993 as necessary to hold any number of swaged needles 103 with attachedsutures 3994. For example, the planar base 4001 may assume a circular,square, oval, rectangular, multi-faceted, or any other shape.

In some embodiments, the top and bottom of the spindles include acoupling the top coupling having a first shape and the bottom couplingbeing shaped to receive the top coupling. In some embodiments, the topand bottom of the spindles include a coupling. The top coupling having afirst shape and the bottom coupling being shaped to engage with thefirst shape of the top coupling. In some embodiments, the top of thespindle includes an extension and the top of the spindle includes arecess shaped to receive the extension.

FIGS. 401A-401C, FIGS. 402A-402C, FIGS. 403A-403C, and FIGS. 404A-404Cillustrate exemplary embodiments of a base for mounting one or moredevices for dispensing and/or securing a plurality of needles, inaccordance with many embodiments. FIG. 401A, FIG. 402A, FIG. 403A, andFIG. 404A illustrate perspective views of exemplary embodiments of abase 4011. FIG. 401B, FIG. 402B, FIG. 403B, and FIG. 404B illustrate topviews of the exemplary embodiments of base 4011 shown in FIG. 401A, FIG.402A, FIG. 403A, and FIG. 404A, respectively. FIG. 401C, FIG. 402C, FIG.403C, and FIG. 404C illustrate end views of the exemplary embodiments ofbase 4011 shown in FIG. 401A, FIG. 402A, FIG. 403A, and FIG. 404A,respectively.

Base 4011 may comprise a planar structure 4010 c, a planar structure4010 a, in some instances a planar structure 4010 b, and in someinstances a planar structure 4010 d. Planar structure 4010 c may beconsidered the base planar structure of base 4010 (i.e., in use itprimarily lays in the horizontal), and may be placed on or coupled tosurgical drapes, tables, stands, and the like via coupling means at itsunderside (e.g., Velcro, adhesive, magnets, mechanical joining means,and the like). Planar structure 4010 c may comprise a rectangularconfiguration with a length and width as appropriate to providestability to base 4010. Planar structure 4010 a, including a mountingsurface, may be coupled to planar structure 4010 c at a living hinge4011 a, with an interior angle 4012 defining the angle between theplanar structure 4010 c and planar structure 4010 a. Planar structure4010 a may be considered the planar surface or may include a planarsurface that is a mounting surface whereon the needle dispensers, needlereceptacles, and various tools as described herein may be coupled foruse during surgical procedures. Thus, planar structure 4010 a maycomprise a surface configured to couple to the needle dispensers, needlereceptacles, and various tools as described herein (e.g., may compriseVelcro, adhesive, magnets, mechanical joining means, and the like).Further, planar structure 4010 c may comprise a rectangularconfiguration with a length and width as appropriate for coupling theneedle dispensers, needle receptacles, and various tools as describedherein thereto. In some embodiments (as shown in FIGS. 401A-401C, FIGS.402A-402C, and FIGS. 404A-404C), planar structure 4010 b may be coupledto planar structure 4010 b at a living hinge 4011 b. Planar structure4010 b may be considered a supporting structure in that it may restagainst planar structure 4010 c and provide further structural stabilityto base 4010. In some embodiments, planar structure 4010 b may restagainst planar structure 4010 c (as shown in FIGS. 401A-401C). In someembodiments, planar structure 4010 c may rest against or engage with theplanar structure 4010 c at stops 4013, or adjustment structures, ofplanar structure 4010 c, wherein the stops 4013 may be configured withan inter-stop spacing 4013 a to present the surface of planar structure4010 a via its connection to planar surface 4010 b as desired asdescribed further herein (i.e., to provide for adjustability of interiorangle 4012 as shown in FIGS. 404A-404C). In some embodiments (as shownin FIGS. 402A-402C), planar structure 4010 d may be coupled to planarstructure 4010 b at a living hinge 4011 c. Planar structure 4010 d maybe oriented co-planar with planar structure 4010 c and rest againstplanar structure 4010 c. In some embodiments, the surface of planarstructure 4010 d that rests against planar structure 4010 c may becoupled to the surface of planar structure 4010 c that it rests against(e.g., by Velcro, adhesive, magnets, mechanical joining means, and thelike). In this way, in these embodiments the coupling of planarstructure 4010 d to planar structure 4010 c may provide foradjustability of interior angle 4012.

In some embodiments, the living hinge 4011 a, the living hinge 4011 b(if present), and living hinge 4011 c (if present) may comprise passivehinges. In some embodiments, the living hinge 4011 a, the living hinge4011 b (if present), and living hinge 4011 c (if present) may compriseactive hinges. In some embodiments, the living hinge 4011 a, the livinghinge 4011 b (if present), and living hinge 4011 c (if present) maycomprise a passive or active hinge.

In some embodiments, the base 4010 may be configured for infiniteadjustability of interior angle 4012. In some embodiments, the base 4010may be configured for finite adjustability of interior angle 4012. Inmany embodiments, the base 4010 may be configured to present the surfaceof planar structure 4010 a configured to couple to the needledispensers, needle receptacles, and various tools as described herein(e.g., via Velcro, adhesive, magnets, mechanical joining means, and thelike) at an angle desired by the surgeon by adjustability of interiorangle 4012. In preferred embodiments, the interior angle 4012 may beadjustable between 30 degrees and 90 degrees, between 60 degrees and 75degrees, between 45 degrees and 75 degrees, or between 60 degrees and 90degrees.

In many embodiments, the coupling of base 4010 to surgical drapes,tables, stands, and the like via coupling means located at the undersideof planar structure 4010 c may be releasable. In many embodiments, thecoupling of base 4010 to surgical drapes, tables, stands, and the likevia coupling means located at the underside of planar structure 4010 cmay be releasable and may not pull, tear, or otherwise damage thesurgical drapes, tables, stands, or the like it is coupled thereto. Inmany embodiments, the strength of the coupling of base 4010 to surgicaldrapes, tables, stands, and the like via coupling means located at theunderside of planar structure 4010 c may be stronger than the couplingof needle dispensers, needle receptacles, and various tools as describedherein to the surface of planar structure 4010 a.

FIGS. 405A-405B illustrate exemplary mounting positions of a base forcoupling one or more devices for dispensing and/or securing a pluralityof needles or for coupling one or more tools as described herein, inaccordance with many embodiments. FIG. 405A illustrates a top view of anexemplary embodiment wherein one or more bases 4010 as described inFIGS. 401A-401C, FIGS. 402A-402C, FIGS. 403A-403C, and FIGS. 404A-404Care mounted to a surgical drape 4052 covering a patient 4050 resting onan operating room table 4051. FIG. 405B illustrates a top view of anexemplary embodiment wherein one or more bases 4010 as described inFIGS. 401A-401C, FIGS. 402A-402C, FIGS. 403A-403C, and FIGS. 404A-404Care mounted to one or more surgical trays, tables, and/or stands 4056 inthe operating room

As shown in FIG. 405A, surgical drape 4052 may comprise a window 4054exposing an incision 4055 in patient 4050. One or more bases 4010 may becoupled to surgical drape 4052 to allow coupling of one or more of theneedle dispensers, needle receptacles, and various tools as describedherein. With reference to the X-Y axes, one or more bases 410 may becoupled to surgical drape 4052 in any X-Y position, and at any anglerelative to the X-axis or Y-axis as desired by a surgeon 4053 performingthe operation. In some embodiments, one or more bases 4010 may becoupled to surgical drape 4052 parallel to the X-axis. In someembodiments, one or more bases 4010 may be coupled to surgical drape4052 parallel to the Y-axis. In some embodiments, one or more bases 4010may be coupled to surgical drape 4052 at any angle relative to theX-axis or Y-axis. In some embodiments one or more bases 4010 may becoupled to surgical drape 4052 near the dominant-arm side of surgeon. Insome embodiments one or more bases 4010 may be coupled to surgical drape4052 near the non-dominant-arm side of surgeon. In some embodiments oneor more bases 4010 may be coupled to surgical drape 4052 in front of theof surgeon. In some embodiments, one or more bases 4010 may be coupledto surgical drape 4052 in the near surgical field. In some embodiments,one or more bases 4010 may be coupled to surgical drape 4052 outside thenear surgical field. In some embodiments, one or more bases 4010 may becoupled to surgical drape 4052 in any combination of positions asdescribed herein.

In various embodiments, the support, also called a base 4010, may bemounted to a drape over the over a patient, within the near surgicalfield, to a table within the near surgical field, to a stand within thenear surgical field, at a location opposite the surgeon from anincision, proximal the incision of the patient, distal the incision ofthe patient, superior to the incision of the patient, or inferior theincision of the patient.

As shown in FIG. 405B, surgical drape 4052 may comprise a window 4054exposing an incision 4055 in patient 4050. One or more bases 4010 may becoupled to one or more surgical trays, tables, and/or stands 4056 toallow coupling of one or more of the needle dispensers, needlereceptacles, and various tools as described herein. With reference tothe X-Y axes, one or more bases 410 may be coupled to one or moresurgical trays, tables, and/or stands 4056 in any X-Y position, and atany angle relative to the X-axis or Y-axis as desired by a surgeon 4053performing the operation. In some embodiments, one or more bases 4010may be coupled to one or more surgical trays, tables, and/or stands 4056parallel to the X-axis. In some embodiments, one or more bases 4010 maybe coupled to one or more surgical trays, tables, and/or stands 4056parallel to the Y-axis. In some embodiments, one or more bases 4010 maybe coupled to one or more surgical trays, tables, and/or stands 4056 atany angle relative to the X-axis or Y-axis. In some embodiments one ormore bases 4010 may be coupled to one or more surgical trays, tables,and/or stands 4056 near the dominant-arm side of surgeon. In someembodiments one or more bases 4010 may be coupled to one or moresurgical trays, tables, and/or stands 4056 near the non-dominant-armside of surgeon. In some embodiments one or more bases 4010 may becoupled to one or more surgical trays, tables, and/or stands 4056 infront of the of surgeon. In some embodiments, one or more bases 4010 maybe coupled to one or more surgical trays, tables, and/or stands 4056 inthe near surgical field. In some embodiments, one or more bases 4010 maybe coupled to one or more surgical trays, tables, and/or stands 4056outside the near surgical field. In some embodiments, one or more bases4010 may be coupled to one or more surgical trays, tables, and/or stands4056 in any combination of positions as described herein. In someembodiments, further adjustability in the location of one or more bases4010 may be attained through movement and/or rotation of the one or moresurgical trays, tables, and/or stands.

FIGS. 406A-406C illustrate exemplary kits including one or more devicesfor dispensing and/or securing a plurality of needles, in accordancewith many embodiments. As shown in the top views of FIGS. 406A-406C(with a top packaging of the kit removed for clarity), kits 4060 maycomprise sheet structure 4061 having a length 4061 h and width 4061 wconfigured to contain internal contents. Internal contents of kits 4060may comprise one or more of a needle dispenser 101 with needles 103, oneor more of a needle receptacle 331 or 3920 or the like, and/or one ormore barrier mounting base 3693 as described herein. Furthermore, inmany embodiments, the internal contents of kits 4060 may comprise one ormore of a needle dispenser 101 with needles 103, one or more of a needlereceptacle 331 or 3920 or the like, and/or one or more barrier mountingbase 3693 complementarily sized to each other as described herein.

As shown in FIG. 406A, kit 4060 may comprise one or more of a needledispenser 101 with needles 103, which may be combined to form a suturepack with needles 103, one or more of a needle receptacle 331, and/orone or more barrier mounting base 3693, all packaged coplanar. In manyembodiments, the needle dispenser 101, needle receptacle 331, andbarrier mounting base 3693 may be any of the needle dispensers, needlereceptacles, and/or barrier mounting bases as described herein (i.e.,needle receptacle 3920 may be contained within kit 4060).

As shown in FIG. 406B, kit 4060 may comprise one or more of a needledispenser 101 with needles 103, one or more of a needle receptacle 331,and/or one or more barrier mounting base 3693, with the needle dispenser101 and needle receptacle 331 coupled to barrier mounting base 3693. Inmany embodiments, the needle dispenser 101, needle receptacle 331, andbarrier mounting base 3693 may be any of the needle dispensers, needlereceptacles, and/or barrier mounting bases as described herein (i.e.,needle receptacle 3920 may be contained within kit 4060).

As shown in FIG. 406C, kit 4060 may comprise one or more of a needledispenser 101 with needles 103 coupled to a needle receptacle 3920. Insome embodiments, kit 4060 may comprise one or more of a needledispenser 101 with needles 103 coupled to a needle receptacle 3920without a barrier mounting base (i.e., the lower structure 3922 ofneedle receptacle 3920 may be directly coupled to the needle dispenser101). In some embodiments, and as shown in FIG. 406C, the needledispenser 101 with needles 103 coupled to a needle receptacle 3920 maybe coplanar. In some embodiments, the needle receptacle 3920 coupled tothe needle dispenser 101 with needles 103 may be folded under the needledispenser 101 in the kit packaging, which may be sterile packagingincluding a sterile barrier, such as the sterile enclosure 505 of FIG.308. In these embodiments, the kit height may be increased, however theoverall length 4061 h and width 4061 w may be substantially decreased.

In many embodiments, the kit 4060 may be planar or substantially planar(e.g., to facilitate easy shipping and/or storing). In many embodiments,the top and bottom surfaces of kit 4060 contents may touch the internalwalls of kit 4060 packaging. In many embodiments, the contents of kit4060 may be sterilized. In many embodiments, the length 4061 h and width4061 w of kit 4060 may be minimized so as to minimize the overall sizeof the kit 4060.

Each of the components of the kits 4060, including for example, theneedle dispenser 101 with needles 103, the needle receptacle 3920 andthe barrier mounting base may be contained together within an sterilepackage for distribution.

FIGS. 407-413 illustrate an exemplary embodiment of needle receptacle4070, in accordance with many embodiments. The needle receptacle 4070may comprise many of the structures shown with reference to FIGS.167-179 and FIGS. 309-320, and a person of ordinary skill in the artwill recognize that many of these embodiments are well suited forcombination with each other, as well as other embodiments as shown anddescribed herein. FIG. 407 illustrates a top view of needle receptacle4070, FIG. 408 illustrates a perspective view of needle receptacle 4070,FIG. 409 illustrates an exploded view of needle receptacle 4070, FIG.410 illustrates a left side view of needle receptacle 4070, FIG. 411illustrates a cross-sectional right side view of needle receptacle 4070,FIG. 412 illustrates a cross-sectional end view of needle receptacle4070, and FIG. 413 illustrates a front view of needle receptacle 4070.

In the illustrated embodiment, the needle receptacle 4070 may be asubstantially planar device comprised of an entry zone 4071 and a securezone 4072, as described herein. The needle receptacle 4070 may includean upper structure 4073, an upper structure 4074, a lower structure4075, and a compliant structure 4076. The upper structure 4073 maycomprise a ramp structure 4073 a that couples to and forms a part of thelower structure 4075 and forms an entry way located below a needle slot4077, a needle driver slot 4073 b that intersects the ramp structure4073 a and extends at least partially through the upper structure 4073,and a window 4073 c defined by an opening through the upper structure4073 bound by the continuous upper structure inner wall 4073 d and theramp structure 4073 a. The window 4073 c may be configured tocomplementarily receive a raised planar surface 4074 a of upperstructure 4074, such that when the upper structure 4073 receives theupper structure 4074 from below the raised planar surface 4074 a fitsinto window 4073 c, and a recessed planar surface 4074 b of upperstructure 4074 stops against the underside of upper structure 4073. Theupper structure 4074 may comprise a needle driver slot 4074 c thatextends partially therethrough and in line with the needle driver slot4073 b of upper structure 4073. The upper side of lower structure 4075may comprise a ramp structure 4075 a and a recess 4075 b partially alongits perimeter to complementary receive and couple to the underside ofthe ramp structure 4073 a and a lower protrusion 4073 e of upperstructure 4073. The lower structure 4075 may also comprise a needledriver slot 4075 c that extends partially therethrough and in line withthe needle driver slot 4073 b of upper structure 4073 and needle driverslot 4074 c of upper structure 4074. The compliant structure 4076 may beconfigured to be received by the lower structure 4075 from above,wherein a lower surface of the compliant structure stops against aplanar surface 4075 d of the lower structure 4075. The compliantstructure 4076 may also comprise a needle driver slot 4076 a thatextends partially therethrough and in line with the needle driver slot4073 b of upper structure 4073, the needle driver slot 4074 c of upperstructure 4074, and the needle driver slot 4075 c of lower structure4075. The compliant structure 4076 may also comprise bevels 4076 b atthe entrance of needle driver slot 4076 a to aid in guiding of a needledriver therethrough. When assembled, the needle receptacle 4070 maycomprise the planar needle slot 4077 formed by the empty vertical spacebetween an upper planar surface 4076 c of compliant structure 4076 andthe lower surface of upper structure 4074, and closed in at the sides bythe inner wall 4073 d of upper structure 4073, thus the needle slot 4077may be configured for receiving one or more needles 104. To aid inplacement of one or more needles into the needle slot 4077 of needlereceiver 4070, upper structure 4074 may comprise tabs 4074 d within theentry zone 4071 that may angle vertically away from the opposing andangled down ramp structure 4073 a.

The needle driver slots 4073 b, 4074 c, 4075 c, and 4076 a of needlereceiver 4070 may align and be configured to provide clearance for aneedle driver along the entire length of the needle translation fromentry zone 4071 to secure zone 4072. The needle slot 4077 of needlereceiver 4070 may constrain needles 104 placed therein into a singleneedle depth array, to minimize overall depth profile and facilitateneedle counting. In many embodiments, the compliant structure 4067 mayapply a holding force against one or more needles 104 within the needleslot 4077 and the secure zone 4072 to resist translation of the needleout of the needle slot 4077 and the secure zone 4072. In manyembodiments, the compliant structure 4067 may comprise foam. In manyembodiments, the compliant structure 4067 may comprise a compliantelement. In many embodiments, the upper structure 4074 may apply aholding force against one or more needles 104 within the needle slot4077 and the secure zone 4072 to resist translation of the needle out ofthe needle slot 4077 and the secure zone 4072.

In a preferred embodiment, the needle 104 is moved into contact betweenthe ramp structure 4073 a and the tabs 4074 d of upper structure 4074 atentry zone 4071 of needle receptacle 4070 by the surgeon manipulatingthe tip of the needle driver in the needle driver slots of needlereceptacle 4070 as described herein. The needles 104 can be pushed intothe entry zone 4071 towards the needle slot 4077 and become aligned withthe needle slot 4077 of needle receptacle 4070. The needles 104 can thenbe moved in translation along the longitudinal axis of the needlereceptacle 4070 (i.e., the axis of orientation of the needle driverslots) from the entry zone 4071 into the secure zone 4072 where theneedles 104 slide into the needle slot 4077 with the convex side facingthe secure zone 4072 and the sharp tip and tail of the needle 104 facingthe entry zone 4071. The needle driver can move the used needles 104into the needle slot 4077 in the secure zone 4072 until the needledriver runs into the end of the needle slots of needle receptacle 4070or the last inserted used needle 104.

In different embodiments, the needle receptacle 4070 can have differentdimension depending upon the size of the needles 104 being received.Thus, a small needle receptacle 4070 used to receive smaller needles 104can have smaller dimensions than a large needle receptacle 4070 used tostore larger needles.

Structural components of needle receptacle 4070 may be joined asdescribed herein (e.g., adhesive, mechanical fits, welds). The undersideof needle receptacle 4070 may be configured to attach and/or couple(e.g., by hook and look couplings, adhesive) to many of the structuresdescribed herein, including barriers, barrier mounting bases, bases, andthe like. In many embodiments, needle receptacle 4070 may be configuredto releasably attach to many of the structures described herein.

FIGS. 414-418 illustrate an exemplary embodiment of needle receptacle4140, in accordance with many embodiments. The needle receptacle 4140may comprise many of the structures shown with reference to FIGS.167-179, FIGS. 309-320, FIGS. 392A-392F, and FIGS. 392A1-392A12, and aperson of ordinary skill in the art will recognize that many of theseembodiments are well suited for combination with each other, as well asother embodiments as shown and described herein. FIG. 414 illustrates atop view of needle receptacle 4140, FIG. 415 illustrates a front view ofneedle receptacle 4140, FIG. 416 illustrates a left side view of needlereceptacle, FIG. 417 illustrates a perspective view of needle receptacle4140, and FIG. 418 illustrates an exploded view of needle receptacle4140.

In the illustrated embodiment, the needle receptacle 4140 may be asubstantially planar device comprised of a secure zone 4142, asdescribed herein. The needle receptacle 4140 may also comprise a landingzone 4141, as described herein. The needle receptacle 4140 may includean upper structure 4143, a lower structure 4146, and a needle slot 4149disposed between the upper structure 4143 and the lower structure 4146.The needle slot 4149 may be configured for securing one or more needles,as described herein. The needle slot 4149 of needle receiver 4140 mayconstrain needles placed therein into a single needle depth array, tominimize overall depth profile and facilitate needle counting asdescribed herein. The needle slot 4149 may be enclosed at all sidesexcept at end 4143 a of the upper structure 4143, in accordance withmany embodiments described herein. The lower structure 4146 may comprisea channel 4146 a formed in the upper surface thereof. The channel 4146 amay be sized to receive a needle driver tip. The upper structure 4143may comprise a stiff structure 4144, a flexible structure 4145, and aneedle driver slot 4148 formed between the stiff structure 4144 and theflexible structure 4145.

The needle driver slot 4148 may be formed between an edge 4145 a of theflexible structure 4145 and an edge 4144 a of the upper structure. Inmany embodiments, edge 4145 a of the flexible structure may separatefrom edge 4144 a of the stiff structure to receive a needle driver, asdescribed herein. In many embodiments, edges 4145 a and 4144 a maycontact each other in a non-deformed free standing state without aneedle driver extending therebetween. In some embodiments, edges 4145 aand 4144 a may be spaced apart from each other in a non-deformed state,a gap being defined therebetween.

The needle receptacle 4140 may comprise a compliant structure 4147disposed between the upper surface of the lower structure 4146 and thelower surface of the stiff structure 4144. In many embodiments, thecompliant structure 4147 may apply a holding force against one or moreneedles within the needle slot 4149 and the secure zone 4142 to resisttranslation of the needle out of the needle slot 4149 and the securezone 4142. In many embodiments, the upper structure 4143 may apply aholding force against one or more needles within the needle slot 4149and the secure zone 4142 to resist translation of the needle out of theneedle slot 4149 and the secure zone 4142. In many embodiments, thecompliant structure 4147 may comprise foam. In many embodiments, thecompliant structure 4147 may comprise a compliant element.

In many embodiments, the needle driver slot 4148 may be disposedparallel to channel 4146 of the lower structure 4146. In manyembodiments, the needle driver slot 4148 may be disposed parallel to andabove channel 4146 of the lower structure 4146.

In many embodiments, a portion of the lower structure 4146 may extendbeyond end 4143 a of the upper structure 4143, forming a landing zone4141. In some embodiments, the needle may be placed in contact with theupper surface of the extended portion of the lower structure 4146 withthe needle driver tip holding the needle aligned with the needle driverslot 4148 of needle receptacle 4140. In some embodiments, channel 4146may extend into the landing zone 4141. In some embodiments, the needlemay be placed in contact and within channel 4146 of the upper surface ofthe extended portion of the lower structure 4146 with the needle drivertip holding the needle aligned with channel 4146 of the lower structure4146 and needle driver slot 4148 of needle receptacle 4140.

In some embodiments, stiff upper structure 4143 and flexible upperstructure 4145 may comprise beveled edges 4144 b and 4145 b,respectively, at opposing sides of needle driver slot 4148. The bevelededges 4144 b and 4145 b may facilitate easy locating of the needledriver into the needle driver slot 4148 when placing needles in needlereceptacle 4140.

In different embodiments, the needle receptacle 4140 can have differentdimension depending upon the size of the needles being received. Thus, asmall needle receptacle 4140 used to receive smaller needles can havesmaller dimensions than a large needle receptacle 4140 used to storelarger needles.

Structural components of needle receptacle 4140 may be joined asdescribed herein (e.g., adhesive, mechanical fits, welds). The undersideof needle receptacle 4140 may be configured to attach and/or couple(e.g., by Velcro, adhesive) to many of the structures described herein,including barriers, barrier mounting bases, bases, and the like. In manyembodiments, needle receptacle 4140 may be configured to releasablyattach to many of the structures described herein. In some embodiments,needle receptacle 4140 may be configured to be received by a receivingelement or other structure as described herein.

Forceps Mounted Receptacle: The dispenser, trap and forceps may comprisean all in one sterile configuration. These can be manufactured together,with each being disposable. The forceps could contain the suturematerial, for example.

The needles can be packaged with the barrier as a unit. The needles canbe arrayed for deployment from the barrier wall with the barrier havingan area available for suture coiling.

Alternatively, suture coiling may not be provided. The packaging can beconfigured to be dispensed from the barrier or the forceps.

It can be easier to load a trap onto a forceps along with the suturepack and have five or so such “set ups” ready on the Mayo stand. Whenone has been used up, it can be placed the Mayo and the next onegrabbed.

The combination of both dispensing unit (suture package) and used needlerepository can be associated together on the forceps.

More than one setup of a suture package and needle receptacle can becombined and ready for use.

The sterile packaging may comprise disposable single use forceps, needleand suture dispenser in combination with a used needle receptacle. Thesecan be co-manufactured.

The forceps mounted receptacles may comprise one or more of manydifferent shapes and sizes. The weight can be sufficiently low in orderto provide balance to the forceps mounted instrument. The needlereceptacles configured for mounting on the forceps can be configured toprovide a balanced surgical instrument with the attachment of needleretention device onto the forceps.

Any design weighing less than 250 grams.

The needle receptacle can be located on one side of forceps, dispensingunit (suture pack) on the other side to save space and volume. Theforceps can be easily be rotated to gain access to one or other sidewhen the suture package and needle receptacle are mounted on opposingsides of the forceps.

The needle receptacle may comprise adhesive and can be placed on theback of suture pack or vice versa.

The needle receptacle and suture package can be configured to use a backto back on opposing sides relationship of needle dispensing device andneedle receptacle.

The suture packs and needle receptacles as described herein can beconfigured to coupled to, for example attach, to the forceps that allowsfor containment, coverage, securement, of both tip and end (tail) of oneor more needles.

The needle arrangement in the receptacle may not need to be planar, andcan be stacked into trough, side by side, for example.

The forceps mounted needle receptacle as described herein can promote anorganized deposition or array of used needles to facilitate counting andreconciliation of needle count.

Needle Count Reconciliation: The scrub assistant and circulator often tomaintain an ongoing count of needles (needles in use, needles in thefield, needles on the mayo stand, needles on the back table). Thereceptacle can be specifically designed to hold five needles for easycounting by the surgeon and staff. This can facilitate reconciliationand communication with the rest of the team. The trap or securement,containment device can be specifically designed for five needles, andsized and shaped accordingly. The needle receptacle as described hereinmay comprise five zones, one for each needle. For example five tactileprotrusions as described herein can be used to facilitate localizationinto each of the five individual zones.

One or more of the needle receptacle, the barrier or the suture packagemay comprise light sources to indicate needle status. Five lightsources, one for each needle entry into the trap, can be provided, forexample. Five light sources on could mean five needles in thereceptacle. This configuration could be easier to see from a distance.These sources could be in the trap (receptacle) or there could be ameans of communication between trap and barrier with light sources onthe barrier. Lighting could be anywhere on the barrier, but be preferredif lighting is dorsal for ease of visualization by the assistant such asa scrub nurse, for example when the trap is on the volar surface andperhaps less visible for the assistant to see. Both volar lighting anddorsal lighting could be provided, for example. There could be five zonespecific light sources with one light on per needle into the trap, forexample with light sources on the trap. Five light sources on the trapcould be in communication with the barrier, and the five lights on thebarrier light up according to number of needles in the trap.

This longitudinal receptacle that receives needles with sliding couldhave five stops with each stop representing an additional needle addedto the slot. The longitudinal sliding cover can be spring loaded. Eachtime the needle driver is abutted against the leading edge of the cover,it triggers a unit translational movement. This movement can be repeatedwith each needle entry until the slot is fully covered. Eachtranslational unit movement can be numbered 1 through five.

The needle receptacle (for example having a slot to receive needles andthe driver) can be configured with ratcheted counting mechanism. Therecan be an active count of needles to be dispensed as well. A user canstart with five needles in the dispenser and zero in the trap (0:5). Theuser would end with (5:0), when needles are reconciled. The apparatuscan be configured with five light sources on the dispenser and countdown to zero. This reconciliation by lighting can be helpful.

In some embodiments, the needle receptacle comprises means forreconciling needles during or after the procedure.

In some embodiments, a first set of needles from a first suture pack arereconciled before a second suture pack enters the near surgical field.

In some embodiments, a dispensed needle receptacle comprising five ormore dispensed surgical needles is received from a surgeon, wherein thedispensed surgical needles are stabilized and innocuous within theneedle receptacle, the needle receptacle comprising one or more of anopening, a window or a transparent material for counting the stabilizedinnocuous dispensed needles, wherein the needles are arranged forcounting within the receptacle.

In some embodiments, a dispensed needle receptacle comprising five ormore dispensed surgical needles is received from a person who reconciledthe surgical needles, wherein the dispensed surgical needles arestabilized and innocuous within the needle receptacle, the needlereceptacle comprising one or more of an opening, a window or atransparent material for counting the stabilized innocuous dispensedneedles, wherein the needles are arranged for counting within thereceptacle.

The kits shown in FIGS. 379A-379C are provided by way of example only,and many different kits may be assembled to accommodate specific uses orprocedures, for example, arterial line or central line placement.

In some embodiments of needle receptacles disclosed herein, a housing ofa needle receptacle may include a light scattering material or a lightscattering surface for non-uniform light transmission therethrough. Insome embodiments the upper or lower structure or surface of the upper orlower structure may be the light scattering surface or material. Thelight scattering surface or material may be a roughened surface or asandblasted surface.

With respect to FIG. 171 and other embodiments of needle receptacles,the inner surface of the upper structure may have protrusions or nubs361, also referred to as tactile bumps. The upper structure may include2-20 tactile bumps, 5-8 tactile bumps, or 3-10 tactile bumps.

With reference to FIGS. 334A-334C and other embodiments herein, theneedle receptacle or suture pack may be placed such that dispensing orsecuring a needle from or to the suture pack or needle receptacle doesnot require external rotation 3345 a of the arm or shoulders beyond aplane perpendicular to the coronal plane of the surgeon at the surgeon'sshoulder, therefore allowing the user to engage only fine motor control,rather than gross motor control, to perform movements related to thedispensing and securing of needles.

In some embodiments, the needle receptacle or suture pack may be placedsuch that dispensing or securing a needle from or to the suture pack orneedle receptacle does not require external rotation 3345 a of the armor shoulders with respect to a sagittal plane that bisects the coronalplane at the surgeon's shoulders, therefore allowing the user to engageonly fine motor control, rather than gross motor control, to performmovements related to the dispensing and securing of needles.

In some embodiments, the needle receptacle or suture pack may be placedsuch that dispensing or securing a needle from or to the suture pack orneedle receptacle does not require external rotation 3345 a of the armor shoulders with respect to a mid sagittal plane of the surgeon,therefore allowing the user to engage only fine motor control, ratherthan gross motor control, to perform movements related to the dispensingand securing of needles.

In some embodiments, the needle receptacle may be placed or otherwiseconfigured such that securing a needle into the needle receptacle usesonly gross motor movement of the surgeon.

In some embodiments, the needle receptacle may be placed or otherwiseconfigured to facilitate needle insertion into the needle receptacleusing only articulation or rotation of the shoulder or elbow joints of asurgeon.

In some embodiments, the resistance of the needle driver along theneedle driver slot is less than the resistance of the needle along theneedle slot when the needle is advanced along the slot with a needledriver.

The systems and methods as described herein may be used to safely handlesutures during procedures involving non-living subjects, such as duringthe performance of autopsies on cadavers, wherein the person operatingon the subject may still be exposed to blood-borne pathogens.Alternatively or in combination, the systems and methods describedherein may be used to safely handle sutures during procedures involvingnon-human subjects, such as during the performance of an operation of ananimal (e.g., in a veterinary practice or in animal studies).

While preferred embodiments of the present invention have been shown anddescribed herein, it will be obvious to those skilled in the art thatsuch embodiments are provided by way of example only. Numerousvariations, changes, and substitutions will now be apparent to thoseskilled in the art without departing from the invention. It should beunderstood that various alternatives to the embodiments of the inventiondescribed herein may be employed in practicing the invention. It isintended that the following claims define the scope of the invention andthat methods and structures within the scope of these claims and theirequivalents be covered thereby.

1. A needle receptacle comprising: an enclosure comprising a needle slotextending from an opening to a secure zone of the enclosure; a needledriver slot extending through a portion of the enclosure to the needleslot; and a needle receiver sized and shaped to receive one or moreneedles and move along the needle slot with advancement of the one ormore needles into the secure zone.
 2. The needle receptacle of claim 1,wherein the needle receiver comprises an elongate body shaped to bereceived within the secure zone.
 3. The needle receptacle of claim 2,wherein the elongate body of the needle receiver comprises an uppersurface shaped to receive the one or more needles.
 4. The needlereceptacle of claim 1, wherein the needle receiver comprises one or moreneedle receiving tabs extending from an upper surface.
 5. The needlereceptacle of claim 4, wherein the one or more needle receiving tabs isconfigured to be engaged with the one or more needles to allow theneedle receiver to slide with the one or more needles when the one ormore needles moves into the secure zone.
 6. The needle receptacle ofclaim 5, wherein the needle receiver is configured to translate towardthe secure zone when the one or needles engages the one or morereceiving tabs and translates into the secure zone of the needle slot 7.The needle receptacle of claim 1, where in the needle receiver isconfigured to allow the one or more needles to pull a portion of theneedle receiver into the needle slot when a needle driver slides alongthe needle driver slot and advances the one or more needles into thesecure zone.
 8. The needle receptacle of claim 1, further comprising anaperture though the lower structure and within an entry zone or atransition zone of the lower structure, wherein the needle receiver isconfigured to pass from underneath the lower structure, though theaperture, and into the needle slot.
 9. The needle receptacle of claim 1,wherein one or more needle receiving tabs is connected to an uppersurface of the needle receiver.
 10. The needle receptacle of claim 9,wherein the one or more needle receiving tabs has been formed by cuttinga slit though the needle receiver and deforming the receiving tab formedby the slit in a direction though the upper surface of the needlereceiver.
 11. The needle receptacle of claim 9, wherein the one or moreneedle receiving tabs has been formed by cutting a slit though theneedle receiver and deflecting the one or more needle receiving tabsformed by the slit in a direction though the upper surface of the needlereceiver.
 12. The needle receptacle claim 1, wherein needle receiver isconfigured to ratchet into the needle slot.
 13. The needle receptacle ofclaim 1, wherein needle receiver is configured to permit movement of theneedle receiver into the needle slot and resist movement of the needlereceiver out of the needle slot.
 14. The needle receptacle of claim 1,wherein one or more needle receiving tabs is configured to hold theneedles within the needle slot in a spaced apart array.
 15. The needlereceptacle of claim 14, wherein the array comprises an ordered array.16. The needle receptacle of claim 1, wherein the needle driver slotextends through the upper structure and the lower structure.
 17. Theneedle receptacle of claim 1, wherein the needle receiver comprises aflexible material.
 18. The needle receptacle of claim 1, wherein theneedle receiver comprises one or more openings to receive a tip of aneedle driver.
 19. The needle receptacle of claim 1, wherein the needlereceptacle comprises one or more protrusions sized and shaped to engagethe one or more needles to advance the needle receptacle toward thesecure zone.
 20. The needle receptacle of claim 1, wherein the needlereceptacle comprises one or more channels sized and shaped to engage theone or more needles to advance the needle receptacle toward the securezone.